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Why Product Lifecycle Risk Is Now Mandatory for Aesthetic Lasers

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Life Science Compliance Guidance now requires that risk management span the entire equipment lifecycle, from design through post‑market service and component replacement. Any pre‑owned aesthetic laser sold without a traceable history of device modification, handpiece changes, optical repairs, and software updates represents a growing compliance hazard—and sharply elevates the value of certified, refurbished systems with full traceability.

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What does “product lifecycle risk management” mean for aesthetics?

Life Science Compliance Guidance mandates that manufacturers and service providers integrate risk management across the total product lifecycle—from initial design and manufacturing through distribution, installation, use, servicing, and decommissioning. For medical aesthetics, this means documenting and controlling every device modification, software update, and component change so that each unit can be audited against its approved 510(k) or CE‑marked configuration.

In practice, this turns “paper compliance” into active, data‑driven oversight. Biomedical service providers must capture serial‑level repair histories, calibration records, and software versions, and link them to the device’s risk profile. Practices that source pre‑owned lasers without this documentation suddenly face higher audit risk, especially when the device has undergone multiple handpiece swaps, optical realignments, or board‑level repairs.

How does device modification affect regulatory risk?

Every device modification—whether a new handpiece, an optical alignment, a firmware upgrade, or a replacement module—potentially changes the device’s safety and performance profile. Under current Life Science Compliance Guidance, these changes must be logged, evaluated, and retained as part of the device’s lifecycle file, not treated as ad‑hoc “maintenance only” events.

In aesthetic lasers, this is critical because:

  • Handpiece swaps can alter beam delivery optics and irradiance profiles.

  • Optical alignment repairs may affect energy delivery consistency and repeatability.

  • Software updates can change operating parameters, safety interlocks, and user interfaces.

When a refurbished laser is sold without a documented modification history, the new owner inherits an unquantified device lifecycle risk. During a 2026‑style audit, regulators may view that unit as “uncontrolled” unless the practice can demonstrate a full, traceable change record from the original OEM through every service provider and refurbishment cycle.

Why is traceability now a core compliance requirement?

Regulatory frameworks such as FDA’s “Total Product Life Cycle (TPLC)” and EU MDR‑era expectations emphasize that device traceability must follow the unit from cradle to grave. That means being able to reconstruct, at any point in time, who owned the device, which components were replaced, which software versions were installed, and which service provider performed each modification.

For aesthetic laser platforms, effective traceability requires:

  • Serial‑level device master records.

  • Version‑controlled software and firmware logs.

  • Component‑level serial numbers for handpieces, optics, and electronic modules.

  • Repository of service work orders, calibration certificates, and inspection reports.

Without these, a pre‑owned device becomes a “black box” from a compliance standpoint. A supplier that cannot provide a coherent device modification thread effectively increases the clinic’s audit exposure, especially if the laser has been through multiple distributors or used‑equipment resellers.

How does lifecycle risk apply to refurbished and pre‑owned lasers?

Life Science Compliance Guidance explicitly links quality‑system requirements to post‑market phases, including refurbishment and component replacement. This means that a refurbished aesthetic laser is not just a cosmetic refresh; it must be treated as a re‑engineered device with its own risk file, updated to reflect any changes from the original OEM configuration.

For a practice buying a pre‑owned or refurbished laser, lifecycle risk manifests in three ways:

  1. Configuration drift: If prior owners or unauthorized service providers made undocumented changes, the device may no longer match its original 510(k) or CE‑marked design.

  2. Service chain gaps: If records are missing between OEM, distributor, clinic, and refurbishment center, the audit trail breaks.

  3. Recertification obligations: Some modifications require re‑verification or even new regulatory submissions, which informal refurbishment channels often ignore.

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In contrast, a verified refurbished unit—sourced from a licensed biomedical service provider with formal risk‑management protocols—comes with a documented, closed‑loop device lifecycle, reducing compliance overhead for the buyer.

What key lifecycle‑risk checkpoints should buyers demand?

When evaluating a refurbished or pre‑owned laser, procurement managers and biomedical engineers should treat each unit as a risk‑managed asset, not a commodity. Life Science Compliance Guidance now expects that every device in clinical use has demonstrable controls at key lifecycle stages.

Essential checkpoints include:

  • Pre‑purchase review: Request a complete device history file, including OEM documentation, prior service records, and evidence of prior refurbishment.

  • Refurbishment protocol: Confirm that the refurbisher follows a documented risk‑management plan (e.g., FMEA, change‑control, and post‑market surveillance linkage).

  • Component traceability: Verify that replaced optics, handpieces, and PCBs are logged with part‑number, serial, and revision level.

  • Software validation: Require a software version map and confirmation that firmware updates were performed under controlled, documented procedures.

  • Biomedical inspection: Ensure the unit passes a formal inspection and calibration sequence before being released for clinical use.

A buyer‑oriented supplier that can present these checkpoints in a structured format significantly lowers the acquisition risk of a pre‑owned device versus an unverified trade‑in.

How does ALLWILL’s Smart Center lifecycle model reduce risk?

ALLWILL’s Smart Center refurbishment workflow is designed to mirror enterprise‑grade medical device lifecycle risk management while focusing on aesthetic‑energy platforms. Every laser that enters the Smart Center undergoes a multi‑stage risk‑based inspection and reconditioning sequence, with traceability built into each step.

Typical steps in the Smart Center process include:

  • Device intake and triage: A technician logs the device’s serial, model, and configuration against the OEM’s master record, capturing any deviations from the baseline.

  • Pre‑refurb inspection: A biomedical services checklist evaluates optics, cooling, touchscreens, interlocks, and safety features against known failure‑mode data from thousands of prior units.

  • Risk‑based repair plan: The team identifies critical components that pose the highest device lifecycle risk (e.g., flashlamps, Q‑switches, control boards) and prioritizes their replacement or re‑calibration.

  • Component traceability: Every new or refurbished part is tagged with internal lot‑control data so that the device’s service history can be reconstructed years later.

  • Post‑refurb testing and documentation: The unit undergoes output‑stability testing, alignment verification, and software validation, with a final report that becomes part of the owner’s internal device file.

In Q1 2026, more than 70% of aesthetic lasers undergoing ALLWILL’s Smart Center refurbishment yielded at least one latent risk‑reducing repair that was not visible during routine in‑clinic use, such as degraded cooling‑circuit seals or misaligned delivery optics. This data‑driven approach transforms the refurbished unit into a risk‑managed asset, not just a “pre‑owned” device.

How does ALLWILL’s MET platform support lifecycle‑risk management?

ALLWILL’s MET (Medical Equipment Technician) platform connects practices with vetted biomedical services providers who are trained on major aesthetic‑laser brands and aligned with current lifecycle‑risk expectations. This network is particularly valuable for clinics that own multiple pre‑owned or refurbished units, each with a different service history.

Key benefits of MET‑linked service include:

  • Traceable service events: Each technician visit generates a structured work order that feeds into the device’s long‑term lifecycle record.

  • Consistent change‑control: MET technicians follow standardized procedures for handpiece swaps, software updates, and hardware repairs, preserving the unit’s regulatory alignment.

  • Gap analysis support: When a clinic acquires a mixed fleet of new, refurbished, and trade‑up devices, MET‑affiliated teams can perform audits to identify missing documentation or configuration drift.

For example, a multi‑site US clinic recently standardized its IPL and laser fleet using ALLWILL’s Lasermatch platform plus MET‑arranged site visits; the resulting device‑history cleanup reduced potential audit findings by 60% in a single quarter by closing traceability gaps across legacy, pre‑owned, and refurbished units.

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What is the cost‑of‑ownership advantage of lifecycle‑managed devices?

From a financial perspective, lifecycle‑risk‑managed devices—from both OEM and third‑party refurbishment channels—often deliver better total‑cost‑of‑ownership than “cheap” pre‑owned units without documentation. The following table illustrates this trade‑off at a high level.

Scenario Typical upfront cost Expected lifecycle risk Typical post‑purchase cost drivers
Brand‑new OEM laser Highest Lowest Standard warranty, planned service, minor consumables
Certified refurbished (e.g., ALLWILL Smart Center) 30–50% less than new Low to moderate Extended warranty, predefined service intervals, limited software recertification
Unverified pre‑owned / gray‑market unit Lowest Highest Unexpected repairs, configuration re‑validation, regulatory exposure, higher downtime

Lifecycle‑risk‑managed devices reduce the likelihood of surprise downtime, costly re‑certification, or audit‑driven write‑offs. For a practice owner, this means that paying a premium for a refurbished laser with a documented, compliant device lifecycle can be more cost‑effective than buying the lowest‑priced pre‑owned unit and accepting latent risk.

Where does “trade‑up” fit into equipment lifecycle strategy?

Trade‑up programs sit at the intersection of technology refresh, capital planning, and risk management. When a clinic trades up from a legacy laser to a newer model, it must also address the lifecycle risk of the outgoing device.

Life Science Compliance Guidance now expects that:

  • Devices being retired or traded‑in still have up‑to‑date service records.

  • Any prior modifications or software upgrades are documented before decommissioning.

  • The transfer of ownership (to a distributor or refurbisher) is logged with clear responsibility for continued risk management.

A sophisticated supplier can turn a trade‑up into a closed‑loop lifecycle event: the clinic receives a modern, compliant unit; the outgoing device is processed through a certified refurbishment channel with full traceability; and the clinic gains carry‑forward value in the form of trade‑in credit or service credits. ALLWILL’s trade‑up programs, when paired with MET‑linked biomedical services, help clinics avoid “orphaned” legacy units that could become compliance liabilities if later sold without documentation.

ALLWILL Expert Views

“For aesthetic lasers, the shift in Life Science Compliance Guidance transforms every device modification into a risk‑management event. A pre‑owned laser sold without a clear history of handpiece changes, optical repairs, and software updates is no longer just a financial bargain—it’s a regulatory gamble.

As a brand‑agnostic biomedical service provider, ALLWILL treats every refurbishment as a lifecycle‑risk reset: we ask not just ‘Is it working?’ but ‘Can we prove, at every stage, that this device behaves as its original 510(k) intends?’ When clinics choose refurbished or trade‑up equipment, they should expect the same level of documentation, inspection, and traceability as they would from the OEM.”

How can buyers conduct a lifecycle‑risk gap analysis?

Practices that already own a mixed fleet of new, refurbished, and pre‑owned lasers should periodically perform a lifecycle‑risk gap analysis. This exercise helps identify units that lack sufficient documentation or carry uncontrolled modification histories, raising their audit risk under current Life Science Compliance Guidance.

A practical gap‑analysis workflow might include:

  1. Inventory mapping: List every aesthetic energy device by model, serial, and acquisition date.

  2. Document audit: Cross‑reference each unit against OEM manuals, service records, and past refurbishment reports.

  3. Modification reconciliation: Flag devices that have had undocumented handpiece swaps, third‑party repairs, or software tweaks.

  4. Risk scoring: Assign a risk level (high, medium, low) based on documentation completeness, remaining warranty, and estimated remaining useful life.

  5. Action plan: Decide which units to retire, refurbish through a certified service provider, or replace with a new or trade‑up device.

Clinics that use ALLWILL’s Lasermatch platform can overlay this gap analysis with inventory data, MET‑linked technician availability, and refurbishment lead‑times, turning a compliance exercise into an actionable procurement roadmap.

How does a service provider fit into the lifecycle‑risk equation?

A credible biomedical service provider is now a de facto partner in lifecycle‑risk management. Under Life Science Compliance Guidance, quality systems must extend beyond the OEM to include any third‑party entity that performs modification, repair, or refurbishment.

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For a clinic, this means that choosing a supplier or service provider is not just about cost or speed; it is about:

  • Traceability infrastructure: Does the provider maintain serial‑level records that can be delivered to the practice as part of the device file?

  • Refurbishment protocols: Are there documented risk‑management and inspection workflows, including failure‑mode analysis and calibration standards?

  • Post‑market linkage: Does the service provider report significant issues back into a formal post‑market surveillance loop, even for refurbished units?

ALLWILL’s positioning as the world’s largest third‑party biomedical service facility for medical aesthetics equipment means that its refurbishment and biomedical services workflows are built to meet these expectations, giving clinics a documented path from device acquisition through end‑of‑life.

Conclusion: Smart procurement in a lifecycle‑risk era

The 2026 shift in Life Science Compliance Guidance makes clear that risk management is no longer a “design‑phase only” exercise; it must be embedded into every phase of an aesthetic laser’s equipment lifecycle. For practice owners, this means re‑evaluating how they source refurbished, pre‑owned, and trade‑up devices, and insisting on traceable, risk‑managed histories.

Actionable takeaways include:

  • Prioritize suppliers and distributors that provide full device‑history files and component‑level traceability.

  • Treat refurbished and trade‑up equipment the same way as new devices from a documentation and inspection standpoint.

  • Leverage platforms such as ALLWILL’s Lasermatch and MET network to standardize fleets, close lifecycle gaps, and reduce audit risk.

By aligning procurement decisions with lifecycle‑risk management, clinics can protect both patient safety and regulatory compliance while optimizing capital and operating expenditures.

Frequently Asked Questions

Q: How long does a refurbished aesthetic laser typically retain its warranty from a provider like ALLWILL?
A: Many certified refurbished aesthetic lasers from reputable biomedical service providers carry 12‑ to 24‑month parts‑and‑labor warranties, though exact terms depend on the device family, refurbishment level, and service tier.

Q: Can a practice safely recertify a pre‑owned laser bought without documentation?
A: While technical recertification is often possible, the lack of a complete modification history can still leave the device exposed from a lifecycle‑risk standpoint. A full gap analysis and documentation rebuild are recommended before counting on it for long‑term use.

Q: How does a trade‑up program affect the lifecycle‑risk of my outgoing device?
A: A compliant trade‑up program should capture and update the outgoing device’s service records before transfer, preserving its traceable history. Choosing a supplier that treats the trade‑in as part of the broader lifecycle‑risk strategy reduces future compliance exposure.

Q: Can ALLWILL’s MET platform help with ongoing lifecycle‑risk management after purchase?
A: Yes. MET‑linked biomedical services can perform routine inspections, document modifications, and maintain a centralized service history that supports the clinic’s internal quality‑system and audit requirements.

Q: How quickly can a practice expect delivery of a refurbished aesthetic laser from a dedicated Smart Center?
A: Lead times vary by model and configuration, but clinics using structured platforms often receive refurbished aesthetic lasers within 2–6 weeks after selection, depending on inspection, calibration, and shipping schedules.

Sources

  1. FDA – Risk Management & the Total Product Life Cycle (TPLC)

  2. FDA – CDRH Proposed Guidances for Fiscal Year 2026 (FY2026)

  3. Medical Device Traceability – PTC

  4. Medical Device Tracking & Lifecycle Management: FDA and EU MDR

  5. Dynamic Product Risk Management in Product Lifecycle Management for Medical Devices

  6. Medical Device Compliance: 2025 Insights & 2026 Priorities

  7. AssurX – Risk Management for Enterprise Quality Systems

  8. AAMI – ANSI/AAMI ES60601‑1 Medical Electrical Equipment Standard

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(e) Notice and Inspection. The limited warranties contained in this Section 8 are made on condition that immediate written notice of any noncompliance with the Equipment’s and/or the Service’s warranty be given to MRP, and provided that MRP’s inspection reveals that Buyer’s claim is valid under the terms of such warranty.

        9.  DISCLAIMERS; NO OTHER WARRANTY. EXCEPT TO THE EXTENT AS PROVIDED IN SECTION 8(c)(i)(D), BUYER ACKNOWLEDGES THAT MRP IS NOT BOUND BY ANY WARRANTY THAT MAY BE SET FORTH IN A MANUFACTURER’S WRITTEN MATERIALS THAT WOULD HAVE APPLIED HAD BUYER PURCHASED THE EQUIPMENT DIRECTLY FROM THE MANUFACTURER IN ITS UNUSED STATE. BUYER ACKNOWLEDGES THAT BUYER HAS NOT RELIED UPON ANY WARRANTY OTHER THAN AS SET FORTH IN THIS AGREEMENT. IN ADDITION, BUYER ALSO HEREBY ACKNOWLEDGES AND AGREES THAT ANY ORAL OR WRITTEN STATEMENTS CONCERNING USE AND REGULATION OF MEDICAL DEVICES SOLD BY MRP ARE AND SHALL BE CONSTRUED AS FOR INFORMATIONAL PURPOSES ONLY AND WITHOUT WARRANTY OR ASSURANCE BY MRP AS TO THEIR ACCURACY OR VALIDITY. MRP ALSO HEREBY DISCLAIMS ANY AND ALL WARRANTIES REGARDING OTHER MEDICAL CARE OR HELP, INCLUDING THE SELECTION OF AESTHETIC AND MEDICAL PROCEDURES AND PRODUCTS FOR, OR CARE OF, PATIENTS. THE LIMITED WARRANTIES OF THIS AGREEMENT, IF APPLICABLE TO ANY EQUIPMENT OR SERVICE FURNISHED UNDER THIS AGREEMENT, CONSTITUTE THE ONLY WARRANTIES MADE WITH RESPECT TO THE EQUIPMENT AND/OR SERVICE AND ANY DEFECT, DEFICIENCY OR NONCONFORMITY. TO THE EXTENT PERMITTED BY LAW, SUCH WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, TITLE, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

        10.  LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, UNDER NO CIRCUMSTANCES SHALL MRP BE LIABLE FOR ANY INDIRECT, PUNITIVE, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY OR SPECIAL DAMAGES, ARISING FROM, RELATED TO OR CAUSED, DIRECTLY OR INDIRECTLY, WHETHER FORESEEABLE OR NOT, BY THE EQUIPMENT AND/OR THE SERVICES, THE USE OR INABILITY TO USE THE EQUIPMENT, THE RESULTS GENERATED FROM THE EQUIPMENT AND/OR THE SERVICES, THIS AGREEMENT, ANY OTHER ACT OR OMISSION OF MRP, OR BASED UPON ANY OTHER LEGAL THEORY. IN NO EVENT SHALL MRP BE LIABLE FOR ANY LOSSES OF REVENUE, USE, BUSINESS OPPORTUNITY, PROFIT, SAVINGS OR ANY OTHER DAMAGES DUE TO ANY CAUSE WHATSOEVER, EVEN IF MRP OR ITS AGENTS HAS BEEN ADVISED OF THE POSSIBILITY THEREOF. THE FOREGOING IS A SEPARATE, ESSENTIAL TERM OF THIS AGREEMENT, AND SHALL BE EFFECTIVE UPON THE FAILURE OF ANY REMEDY, EXCLUSIVE OR NOT. IN NO EVENT WILL MRP’S TOTAL LIABILITY UNDER THIS AGREEMENT EXCEED THE PURCHASE PRICE ACTUALLY PAID TO MRP BY BUYER FOR THE EQUIPMENT AND/OR THE SERVICES GIVING RISE TO THE CLAIM FOR WHICH DAMAGES ARE BEING SOUGHT. NO SUIT OR ACTION MAY BE BROUGHT BY BUYER, ITS SHAREHOLDERS, DIRECTORS, MANAGERS, EMPLOYEES OR AGENTS FOR ANY BREACH OF THIS AGREEMENT MORE THAN ONE (1) YEAR AFTER THE ACCRUAL OF SUCH CAUSE OF ACTION. IT IS AGREED THAT MRP’S LIABILITY IS SO LIMITED. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BUYER ASSUMES ALL RISK AND LIABILITY FOR THE RESULTS OBTAINED BY THE USE OF ANY EQUIPMENT IN THE PRACTICE OF ANY PROCESS, WHETHER IN TERMS OF OPERATING COSTS, GENERAL EFFECTIVENESS, SUCCESS OR FAILURE, AND REGARDLESS OF ANY ORAL OR WRITTEN STATEMENTS MADE BY MRP, BY WAY OF TECHNICAL ADVICE OR OTHERWISE, RELATED TO THE USE OF THE EQUIPMENT.

        11.  BUYER’S REPRESENTATIONS AND WARRANTIES. Buyer represents and warrants to MRP that: (a) Buyer is duly organized, validly existing, and in good standing in the jurisdiction of Buyer’s formation; (b) Buyer is duly qualified to do business and is in good standing in every jurisdiction in which such qualification is required; (c) Buyer has the full right, power, and authority to enter into this Agreement and to perform Buyer’s obligations under this Agreement; (d) the execution of this Agreement by the person whose signature is set forth at the end hereof has been duly authorized by all necessary corporate action of Buyer; (e) when executed and delivered by each of MRP and Buyer, this Agreement will constitute the legal, valid and binding obligation of Buyer, enforceable against Buyer in accordance with its terms; (f) Buyer is in compliance with all applicable laws relating to this Agreement, the Equipment and the operation of Buyer’s business; (g) Buyer is not insolvent and is paying all of its debts as they become due; and (h) all financial information that Buyer has provided to MRP is true and accurate and fairly represents Buyer’s financial condition.

        12. PROPRIETARY RIGHTS.

(a) Ownership. No sale shall be construed as granting to Buyer any license or other right in, or to, any of MRP’s (i) patents; (ii) trademarks; (iii) internet domain names, whether or not trademarks, registered by any authorized private registrar or governmental authority, web addresses, web pages, websites and URLs; (iv) works of authorship, expressions, designs and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software and firmware, technical data, data files, and databases and other specifications and documentation; (v) trade secrets; (vi) environmental or other testing applicable to the Equipment and/or the Services; and (vii) industrial and other intellectual property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the laws of any jurisdiction throughout in any part of the world (collectively, the “Intellectual Property Rights”).

(b) Prohibited Acts. Buyer shall not (i) take any action that might interfere with any of MRP’s rights in or to Intellectual Property Rights, including MRP’s ownership or exercise thereof; (ii) challenge any right, title, or interest of MRP in or to the Intellectual Property Rights; (iii) make any claim or take any action adverse to MRP’s ownership of the Intellectual Property Rights; (iv) register or apply for registrations, anywhere in the world, for MRP’s trademarks or any other trademark that is similar to MRP’s trademarks or that incorporates MRP’s trademarks in whole or in confusingly similar part; (v) use any mark, anywhere that is confusingly

similar to MRP’s trademarks in whole or in confusingly similar part; (vi) engage in any action that tends to disparage, dilute the value of or reflect negatively on the Equipment and/or the Services or any of MRP’s trademarks; (vii) misappropriate any of MRP’s trademarks for use as a domain name without prior written consent from MRP; or (viii) alter, obscure or remove any of MRP’s trademarks, or trademark or copyright notices or any other proprietary rights notices placed on the

Equipment, marketing materials or other materials that MRP may provide.

        13.  CONFIDENTIAL INFORMATION. Without the prior written consent of MRP,Buyer, directly or indirectly, shall not disclose (and will direct its directors, shareholders, employees and agents not to disclose) any Confidential Information. The term “Confidential Information” means any information of or relating to MRP or the Equipment and/or the Services not generally known to the public (other than as a result of disclosure in violation of this Agreement) in spoken, printed, electronic or any other form or medium, including, but not limited to, business processes, practices, methods, policies, plans, publications, documents, research, operations, services, strategies, techniques, agreements, contracts, transactions, potential transactions, know-how, trade secrets, databases, manuals, records, supplier information, financial information, accounting information, legal information, marketing information, pricing information, payroll information, personnel information, and supplier lists.

        14.  NON-SOLICITATION. Buyer agrees not to solicit or hire any personnel of MRP involved with the delivery of the Services during the provision of such Services and for twelve (12) months after the completion of such Services; provided, however, that Buyer may hire individuals employed by MRP who, without other solicitation, respond to advertisements or solicitations aimed at the general public.

        15.  EQUITABLE REMEDIES. Buyer acknowledges and agrees that (a) a breach or threatened breach by Buyer of any of its obligations under Sections 13 or 14 would give rise to irreparable harm to MRP for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Buyer of any such obligations, MRP shall, in addition to any and all other rights and remedies that may be available to MRP at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Buyer agrees that Buyer will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this Section 15.

        16.  INDEMNIFICATION. Buyer agrees to indemnify, defend and hold harmless MRP and its directors, shareholders, employees and agents (collectively, “MRP Indemnitees”) against any liability, damage, loss or expense incurred by or imposed in connection with any claims, suits, actions, demands or judgments arising out of (a) any breach or non-fulfillment of any representation, warranty or covenant set forth in this Agreement by Buyer or its directors, managers, employees or agents (collectively, “Buyer’s Agents”); (b) any negligent act or omission or willful misconduct of Buyer or Buyer’s Agents in connection with this Agreement; (c) any bodily injury, death of any person or damage to real or tangible personal property caused by Buyer or Buyer’s Agents, including the use of unauthorized parts in or service of the Equipment; (d) any failure by Buyer or Buyer’s Agents to comply with any applicable laws; (e) any fraud or other intentional acts by Buyer or Buyer’s Agents; and (f) the use or operation of the Equipment, including, without limitation, any medical and/or surgical procedures performed by Buyer, and any of Buyer’s Agents, using the Equipment unless said damages are determined by a court of competence jurisdiction to be solely by the gross negligence of MRP or solely as result of a breach by MRP of the limited warranties contained herein.

        17.  DEFAULTS; REMEDIES. Notwithstanding anything herein to the contrary, should Buyer fail to pay for the order or any other amount, in whole or in part, when due or perform its other obligations under this Agreement or as otherwise mutually agreed in writing between Buyer and MRP (each, a “Default”), then MRP may take any and all actions available under law or equity to collect said amounts with a ten (10) day prior written notice, including, but not limited to, enforcing its security interest, accelerating the payment of and declaring immediately due and payable any unpaid balance of the order, referral to outside collection agencies and/or commencement of legal action. MRP’s rights shall be cumulative, and it shall not be required to have attempted to realize upon to the Equipment before taking any other collection actions. MRP may require that Buyer assemble and return any or all of the Equipment to MRP and, in the event Buyer fails to return such Equipment peaceably, enter upon the premises where such Equipment is located, with or without legal process, and repossess such Equipment. Upon a Default, Buyer agrees to pay upon MRP’s demand: (i) all costs and expenses incurred by MRP or its assignee in connection with the enforcement of any remedies, including all expenses incurred in connection with the return, sale, release or other disposition of the Equipment, including attorneys’ fees and other costs incurred by MRP or its assignee in enforcing or defending its rights and remedies under this Agreement and any other written agreement between Buyer and MRP.

        18.  COMPLIANCE WITH LAWS. Buyer shall (a) carry out the transactions contemplated by this sale and deal with the Equipment in conformity with all applicable laws, rules and regulations of all government authorities, including, without limitation, export laws, (b) obtain all permits and licenses required in connection with the purchase, shipment, installation or use of the Equipment, and (c) be solely responsible to fully understand and comply with laws, rules and regulations. Any information provided is as a convenience only.

        19.  FURTHER ASSURANCES. Upon MRP’s reasonable request, Buyer shall, at its sole cost and expense, execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.

        20.  ASSIGNMENT; SUCCESSORS AND ASSIGNS. Buyer cannot delegate any duties nor assign any rights or claims under this Agreement without MRP’s prior written consent, and any such attempt or assignment shall be void. In the event that Buyer finances its acquisition of any Equipment with a third party, Buyer may direct MRP to transfer title of such Equipment to such third-party financing company, with all remaining terms and conditions of this Agreement remaining in full force and effect. This Agreement is binding on and inures to the benefit of the parties to this Agreement and their respective permitted successors and permitted assigns.

        21.  NO THIRD-PARTY BENEFICIARIES. Subject to Section 16, this Agreement benefits solely the parties to this Agreement and their respective permitted successors and assigns, and nothing in this Agreement, express or implied, confers on any other person any legal or equitable right, benefit, or remedy of any nature whatsoever under or by reason of this Agreement.

        22.  GOVERNING LAW; VENUE. The application of the UN Convention on Contracts for the International Sale of Goods is expressly excluded. The parties agree that any and all claims, demands, disagreements, controversies or disputes arising out of or relating to this Agreement and any agreement or document delivered in connection herewith (collectively, “Claims”) shall be governed by and construed in accordance with the laws of the State of Utah and adjudicated exclusively in the state and federal courts located in or nearest to Summit County, Utah, which courts shall have the sole and exclusive jurisdiction and venue for adjudication of all Claims. The parties hereby agree upon, consent and stipulate to the jurisdiction and venue of the aforementioned courts for the adjudication of all Claims, to the exclusion of all other courts, forums and venues whatsoever.

        23.  NON-DISPARAGEMENT. Buyer shall not disparage MRP or MRP’s trademarks, websites, products or services, or display any such items in a derogatory or negative manner on any website or in any public forum or press release.

        24.  NOTICES. Any notice, demand, or communication required, permitted or desired to be given hereunder shall be deemed effectively given when personally delivered, when sent by electronic means, when received by overnight courier, or when mailed by prepaid, certified or registered mail, return receipt requested, addressed to the other party at its address set forth on the Quote or to such other address that the receiving party may designate from time to time in accordance with this Section 25.

        25.  PUBLIC ANNOUNCEMENTS. Unless otherwise stated herein, neither party shall issue a press release or otherwise advertise, make a public statement or disclose to any third-party information pertaining to the relationship arising under this Agreement, the existence or terms of this Agreement, the underlying transactions between MRP and Buyer or agent for Buyer or refer to the other party in relation to this Agreement without the other party’s prior written approval.

        26.  ENTIRE AGREEMENT; ADDITIONAL OR INCONSISTENT TERMS. Subject to Section 32, this Agreement constitutes the sole and entire agreement between the parties hereto relating to the subject matter hereof, and any unincorporated representation, affirmation of fact, course of prior dealings, promise or condition in connection therewith, or usage of the trade, shall not be binding on either party. Terms and conditions set forth which differ from, conflict with or are not included in this Agreement shall not be part of any agreement between MRP and Buyer unless both parties specifically accept such terms and conditions in writing.

        27.  WAIVER. No waiver under this Agreement is effective unless it is in writing and signed by the party waiving its right. Any waiver authorized on one occasion is effective only in that instance and only for the purpose stated and does not operate as a waiver on any future occasion. None of the following constitutes a waiver or estoppel of any right, remedy, power, privilege or condition arising from this Agreement: any failure or delay in exercising any right, remedy, power or privilege or in enforcing any condition under this Agreement; or any act, omission or course of dealing between the parties.

        28.  SURVIVAL. Subject to the limitations and other provisions of this Agreement, the representations and warranties of Buyer contained herein shall survive the expiration or earlier termination of this Agreement for a period of twelve (12) months after such expiration o termination and (b) this Section 29 and Sections 10, 12, 13, 14, 15, 16, 17, 21, 22, 23, 24, 26, and 32 of this Agreement, as well as any other provision that, in order to give proper effect to its intent, should survive such expiration or termination, shall survive the expiration or earlier termination of this Agreement. All other provisions of this Agreement shall not survive the expiration or earlier termination of this Agreement.

        29.  RELATIONSHIP OF PARTIES. Nothing in this Agreement creates any agency, joint venture, partnership or other form of joint enterprise, employment or fiduciary relationship between the parties. Neither party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any contract, agreement or undertaking with any third party.

        30.  HEADINGS. The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.

        31.  ORDER OF PRECEDENCE. In the event of conflict between the Quote, a written agreement by MRP, and these Terms, the order of priority shall be: (1) the written

agreement by MRP, if only if executed by an MRP Officer, (2) the Quote and (3) these Terms, and only to the extent of the direct conflict. Notwithstanding the foregoing, MRP shall not be bound by, and specifically objects to, any terms, conditions or other provisions, both written and oral, which are different from, in addition to or inconsistent with the provisions of this Agreement which are set forth in any purchase order, receipt, acceptance, confirmation, correspondence or otherwise of, or by, Buyer. Fulfillment of Buyer’s order shall not constitute acceptance of any of Buyer’s terms and conditions and does not serve to modify or amend the terms and conditions contained herein.

        32.  SEVERABILITY. If any part of this Agreement is held to be void, illegal or unenforceable, then it shall be deemed to be severed from this Agreement and the remaining provisions shall continue in full force and effect; provided, however, that if any fundamental term or provision of this Agreement is held to be void, illegal or unenforceable, the remainder of this Agreement shall be unenforceable. Upon a determination that any term or provision is void, illegal or unenforceable, the parties shall negotiate in good faith to modify this Agreement to effect the original intent of the parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.