Jon Lendrum

I’m looking forward to joining product compliance engineers, innovators, safety advocates and continuous improvement experts at the 20th Institute of Electrical and Electronics Engineers (IEEE) International Product Safety Engineering Society’s (PSES) International Symposium on Product Compliance Engineering (ISPCE) 2024 April 30-May 2 in Chicago. The event will include discussions and presentations on different engineering disciplines, which have become a growing area of interest to business leaders.    On April 30, I’ll have the honor of delivering this year’s keynote presentation, titled “Changing the Compliance Paradigm in Large Global Companies” in the spirit of sharing best practices and lessons learned over the past 30 years. I’ll provide a suggested roadmap on how to approach the formidable challenge of changing the compliance paradigm in a large, complex, international organization. I’ll also discuss our greatest opportunity and challenge - demonstrating the benefits that earlier Compliance involvement bring to the product development process, and how it can positively affect business results, reduce the amount of time to receive compliance and go to market, and provides customers with better products.   The work that the IEEE PSES and ISPCE 2024 are doing with my Thermo Fisher Scientific colleagues Mark Pearson, Regan Arndt and Ken Kapur, among others - as well as their dedicated counterparts at other companies - are powering the compliance engineering profession across the globe, and the benefits it will bring customers and companies. #thermofisher #QualityProfessionals #QualityAssurance #RegulatoryAffairs #QARA #Regulatory #Quality #IEEE #ISPCE #Compliance

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Maximize the ROI in your investment in your compliance programs.

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NIRS monitoring alerts you to critical changes in your patients — but not all technologies respond the same during blood transfusion. When every second counts, which would you choose? Compare response times of leading NIRS technologies. #MedtronicEmployee https://bit.ly/4irSU3P

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🚨 📢 BREAKING NEWS The FDA made good on their promise and announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA issued a policy to phase out, over the course of four years, its general enforcement discretion approach for LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories. 👀 Read the to be published final rule here (scheduled to be published in the FR 6 May 2024)...be sure to read the preamble!! https://lnkd.in/gyYJk92a 🔎 As part of issuing the final rule, FDA adjusted the phaseout policy and their enforcement discretion policies. The FDA intends to exercise enforcement discretion with regard to premarket review and most quality system requirements for certain categories of IVDs, including but not limited to: 👉 Currently marketed IVDs offered as LDTs that were first marketed prior to the date of issuance of the final rule. This enforcement discretion policy is intended to address the risk that the perceived costs of compliance with such requirements could lead to the widespread loss of access to beneficial IVDs on which patients currently rely. 👉 LDTs manufactured and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system when an FDA-authorized test is not available. This enforcement discretion policy is intended to help avoid patients being deprived of critically needed LDTs where certain risk mitigations exist that may help laboratories to identify any problems with their LDT and may help inform appropriate use and interpretation of such LDTs. 👉 The FDA has also included additional enforcement discretion policies, such as for LDTs approved by the New York State’s Clinical Laboratory Evaluation Program (CLEP), as described in the preamble to the final rule, where that program’s review of analytical and clinical validity helps to mitigate the risk of harm from inaccurate and unreliable LDTs. 🔬 What are your thoughts on the impact of this to clinical laboratories and IVD manufacturers? Along with the final rule, FDA issued two new guidance documents related to LDTs during public health emergencies: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564, https://lnkd.in/gMZTBFby Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency, https://lnkd.in/gWJfs_h3 #medicaldevices #healthcare #compliance #regulatoryaffairs #diagnostics #laboratory #biotech #clinicaltrials #LDT #FDA #clinicalresearch

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Check out the FDA's latest guidance on cybersecurity in medical devices and why it's so critical for safety and regulatory compliance. This covers everything from software to network-enabled devices, ensuring enhanced patient protection. Explore the full guidance here: FDA Guidance on Cybersecurity in Medical Devices #Cybersecurity #MedicalDevices #FDACompliance #SaMD #HealthcareInnovation #PromenadeSoftware #PenTesting #SoftwareDevelopment

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Help ensure accurate EtCO₂ readings (1-3) and improved FiO₂ delivery.(4) Find the right open and closed EtCO₂ masks for your patients. https://lnkd.in/g7Y-Wp6a Product usage represented may not be approved or cleared in all markets. 1. Restrepo RD, Karpenkop I, Liu KE. Evaluation of Capnography Sampling Line Compatibility and Accuracy when Used with a Portable Capnography Monitor. J Vis Exp. 2020;(163). 2. Colman Y, David U. Comparison of Capnography Filter Lines for Nose and Mouth Breathing of End Tidal Carbon Dioxide Sampling With and Without Supplemental Oxygen. STA Annual Meeting Abstracts; January 2009. 3. Based on internal bench testing for EtCO₂ accuracy against Salter Labs, Respironics, Flexicare, Hudson, and Westmed lines. Full comparison white paper available here: https://lnkd.in/g-yvfiiR 4. Burke R, Puddicombe C. SMI First in Human analysis of Oxy2Pro™* FiO2 performance report. 2324-01; 2022. #MedtronicEmployee

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The latest #MDCG 2021-25 Rev. 1, Oct 2024 guidance offers much-needed clarity for #medicaldevices manufacturers managing #legacydevices under the #MDR. A quick breakdown on guidance document as follow: 1. Legacy Devices and Market Requirements > #Postmarketsurveillance, #vigilance, and registration requirements now apply to legacy devices. > Transitional periods extend to systems and #procedurepacks, requiring #compliance where a #notifiedbody is involved. B. Quality Management System (#QMS) Requirements > Manufacturers must implement a QMS aligned with MDR Article 10(9) by May 26, 2024 to continue placing legacy devices on the market. C. #UDI Assignment Scope > UDI verification is required only if applicable for specific devices, ensuring manufacturers avoid unnecessary complexity. D. Reporting Serious Incidents for #LegacyDevices > Even for devices placed on the market pre-MDR, #seriousincidents and #safetyactions must be reported following Article 87 of the MDR. This guidance will help manufacturers to stay compliant while ensuring #patientsafety and seamless market operations.

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Very nice overview about classifications for medical devices. Worth mentioning, the classifications listed below have their own definitions and evaluations path, they work in parallel and usually don’t have direct influence on each other.

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I know what you're thinking..."There's plenty of time". On March 2, 2022, CDRH hosted the Devices Good Manufacturing Practice (DGMP) Advisory Committee Meeting to discuss the proposed rule outlining amendments to the medical device current good manufacturing practices (cGMP) requirements under 21 CFR 820, the Quality System (QS) regulation in an effort to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. Industry was given the opportunity to comment on the docket and various representatives, including myself, were in attendance to provide live feedback. One key point of debate was the transition timeframe that manufacturers would have to comply with the proposed rule. While the FDA had suggested one year, industry felt this was too aggressive and countered with a request for three years. By way of compromise, the deadline of February 2, 2026 was settled upon. Having been in quality and regulatory for decades, one thing I’ve seen is the consistency of procrastination when transitioning to standards and regulatory deadlines. So, while there may be 14 months left before the revised part 820, now titled the Quality Management System Regulation (QMSR), deadline, it’s advised that this can is not kicked down the road. If an organization hasn’t addressed the QMSR yet, they’ve already proven that the one-year proposed timeline was, in fact, manageable. At NSF, we have a course to help understand the requirements of the new QMSR -> https://lnkd.in/ee3WZgjJ Additionally, along with both virtual and on-site instructor-led training courses, we offer a suite of eLearning for many other topics. See here for more information -> https://lnkd.in/eiN3JSG

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🎥 New Video: Standards in the Medical Industry 🎥 In our latest video, Justin Bushko from Concise Engineering breaks down the essential standards in the medical device industry and their critical role in ensuring safety, quality, and compliance. 🔑 Key Takeaways: 🗸 Industry standards like ISO 13485 and IEC 60601 are the foundation of medical device design, development, and production. 🗸 Coordination across departments is vital to maintaining consistency and quality, from design to post-market surveillance. 🗸 Regular training, SOPs, and audits help ensure that teams stay informed and compliant with the latest updates. By adhering to these standards, your medical device will meet the highest quality and safety benchmarks. Watch the video to learn more about navigating these standards and ensuring compliance in your development process! 👉Subscribe to our channel https://lnkd.in/eHWBKWev #MedicalStandards #ISO13485 #IEC60601 #video #medtech #medtechman #medicaldevices #technews

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Last week FDA published the CDRH Proposed Guidances for Fiscal Year 2025: https://lnkd.in/gHWYHMk8 It's broken into A-list Guidances (will do), B-List (want to do) and Under Construction (if you're lucky), followed by a list of past Final Guidances. When FDA publishes a Draft vs Final Guidance, do you treat them differently? Does a Final Guidance hold more weight during your Design & Development or Regulatory process?

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FDA has issued final guidance clarifying the distinction between "remanufacturing" and "servicing" for reusable medical devices. This is a crucial step in ensuring the safety and efficacy of these devices. Understanding these definitions is essential for manufacturers and healthcare providers alike. https://lnkd.in/gF6phyYb #medicaldevices #patrickgora #FDA #healthcare #regulation #compliance #remanufacturing #servicing

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My talented colleague Jim Hammerand sat down with the always-impressive Lisa Earnhardt, EVP and Group President of Medical Devices at Abbott for an action-packed discussion with insights into #medtech innovation and advice for device #engineers. It may be one of my favorite articles to-date! Medical Design & Outsourcing #WomeninMedTech #bestindustryintheworld

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In an article for Medical Devices Zone, Partner Michael Heyl, shares how he guides medical device companies through FDA regulations, requirements and compliance. This article shares tips on the importance of preparing for inspections and the value of strong internal auditing programs.

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Thank you to everyone that attended my webinar on 6/25 about the QMSR changes! You had some great questions and I was happy to share my perspectives. If you haven't had a chance to dive deep on it, here is FDA's ruling: https://lnkd.in/ex8SWZNm Of particular interest is the last 3 pages which previews what it will look like, although the preamble has some great stuff in there too. Check it out! #QMSR #NPG #Quality

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Automated systems for medical manufacturing are complex and deciding where and how to apply them requires a complete understanding of the intricacies involved in equipment development and qualifications. Learn more in this article from MD+DI: https://lnkd.in/gFJR6JyR #TrelleborgMedicalSolutions

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Navigating the complex landscape of EU MDR? Building a compliant quality management system is crucial for medical device manufacturers. My latest blog outlines key steps to ensure your operations meet EU MDR requirements. https://lnkd.in/gEu7QvES #patrickgora #EUMDR #medicaldevices #qualitymanagement #regulation #compliance #healthcare #manufacturing

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Do too many of your corrective or preventive actions fail to effectively stop problems from occurring or recurring? It's most likely because the actual root causes weren't identified, i.e. - the wrong problem was "solved". Come learn how to increase the chances of determining the right root causes to work on. #QRxPartners #QRxInforms #RootCauseAnalysis #CAPA #MLV #MDMMinneapolis

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The first step to a remediation plan is to do a thorough gap analysis of the regulations/audit findings and the QMS. This is critical to developing the plan for getting back into compliance. Next, adjust the QMS policies and procedures to gain compliance and then execute closing the gaps! Let us custom tailor a solution for you! #compliance #remediation #MEC #customsolutions

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