DeviceTalks’ Post

Join us at our Regulatory Roundup on Nov. 13 at Arena, a PTC Business in the Seaport! Designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry, the agenda includes comprehensive presentations by FDA officials, industry representatives and regulatory experts. Agenda highlights include: ⭐ A keynote from Keynote presentation from Dr. Michelle Tarver, Acting Director, CDRH, FDA ⭐ Moderated Q&A session with Dr. Michelle Tarver, facilitated by Veeva MedTech ⭐ Driving Value with the Adoption of AI in Healthcare QARA Systems, presented by IQVIA Technologies ⭐ Which MedTech Companies Will Survive the Coming PCCP Shakeout?, presented by Ketryx ⭐ Laboratory Developed Tests (LDT) and In Vitro Diagnostics as Regulated Medical Devices, presented by Ropes & Gray LLP ⭐ Accelerating Regulatory Approvals & Time to Market with AI-powered Clinical Data and Virtual Twins, presented by Dassault Systèmes ⭐ Insights Into The Development Of IEC 60601-1 4th Edition, presented by Intertek Space is limited! Register now: https://bit.ly/4cmSvML #medtech #regulatory #quality #compliance

Join us at @MassMEDIC’s Regulatory Roundup on Nov. 13 hosted by @Arena, by PTC in the Seaport! Designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry, the agenda includes comprehensive presentations by FDA officials, industry representatives and regulatory experts. We are thrilled to include the newly confirmed Director of the @Center for Devices and Radiological Health, Dr. Michelle Tarver, as our keynote speaker! Space is limited! Register now: https://lnkd.in/eGJH4-Ju As a partner, we are proud to offer our members a 10% discount with code PARTNER10. Agenda highlights include: A keynote from Dr. Michelle Tarver, Director, CDRH, @FDA Moderated Q&A session with Dr. Michelle Tarver, facilitated by @Veeva Medtech FDA’s New Quality Management System Regulation (QMSR) – What’s New and How to Get Ready for the Feb 2026 Implementation Deadline presented by @Arena, by PTC Driving Value with the Adoption of AI in Healthcare QARA Systems, presented by @IQVIA Technologies Which MedTech Companies Will Survive the Coming PCCP Shakeout?, presented by @Ketryx Laboratory Developed Tests (LDT) and In Vitro Diagnostics as Regulated Medical Devices, presented by @Ropes & Gray Accelerating Regulatory Approvals & Time to Market with AI-powered Clinical Data and Virtual Twins, presented by @Dassault Systèmes Insights Into The Development Of IEC 60601-1 4th Edition, presented by @Intertek #medtech #regulatory #quality #compliance

📣 CALLING ALL MEDICAL DEVICE, IVD, SOFTWARE, AND AI/ML REGULATORY PROFESSIONALS! 📣 MedTech Summit US is BACK in Minneapolis from November 5th to 7th 2024 for the second year in a row and you won't want to miss it! This year, we'll be delving into all things medical device, in vitro diagnostic, software and AI/ML regulations, focusing on both European and US regulatory systems. Interested in being involved? Submit a speaker request through the link below or send me a message: https://lnkd.in/eprwZhQV #medtech #medicaldevice #ivd #software #samd #ai #ml #regulatory #regulatoryaffairs #regulation #fda #eucommission #invitro #diagnostic #medtechsummit #medtechsummitus

Switzerland News!! (IVDs) At its meeting on August 14, 2024, the Federal Department of Home Affairs informed the Federal Council that the transition periods for the new requirements for in-vitro diagnostics in Swiss law are to be adjusted and extended in line with Regulation (EU) 2024/1860 amending the EU-IVDR. Amendment of the MedDO and IvDO is planned for autumn 2024. For IVD devices whose certificates were issued in accordance with Directive 98/79 EC (“IVDD”) and which expired before 9 July 2024 or which expire after this date, Swissmedic will tolerate the conditions for extending the validity of the certificate in accordance with the EU-IVDR amendment as part of the enforcement of therapeutic products legislation. In addition, the simplified labelling requirements for certain in-vitro diagnostics are to be continued indefinitely. The already enshrined obligation to register medical devices and in-vitro diagnostics in a central database is to come into force in 2026. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #surveillance #automation #regulatoryintelligence #clinicalinvestigations

A few personal takeaways from RAPS Euro Convergence, IVDR edition: There was great interest in IVD topics at last week’s RAPS Euro Convergence; all IVD sessions were very well attended. The proposed extension of the IVDR transition timelines for legacy products dominated the headlines. -         All manufacturers must implement an IVDR-compliant quality system by May 26, 2025. -         Manufacturers must apply to a notified body by May 2025 for Class D, May 2026 for Class C and May 2027 for Class B and A sterile devices.  Dates for compliance are December 2027 for Class D, December 2028 for Claas C, and December 2029 for Class B and A sterile. -         New devices and devices having undergone significant changes do not benefit from the transition period. -         Devices with IVDD certificates expiring prior to publication of the new rule in the Official Journal can only benefit from the new transition timelines if an application to a notified body is made prior to the expiry date. Despite the intent of the Regulation to create a level playing field for all stakeholders, there is some concern about a lack of harmonization. -         Recognizing the impact of different approaches to conformity assessment, notified bodies have been making progress in common approaches through Team-NB and NBCG-MED. -         There is a need for better harmonization among competent authorities to ensure that the Regulation is applied evenly across the European Union. Seven years from the IVDR’s entry into force, key infrastructure is still missing. -         5 EU Reference Labs have been designated, covering 4 of 8 product groups. These labs are expected to commence operations in October 2024. There are no laboratories covering the remaining 4 product groups. The European Commission intends to launch another call for interested laboratories. Notified bodies have developed risk-based approaches to release high-risk devices in the absence of reference labs. -         Eudamed is not yet fully available. The proposal for phased introduction of Eudamed calls for mandatory implementation of Eudamed modules as they become operational. This is expected to lead to improved tracking of devices and certificates. #RAPSEuroConvergence #TUVSUD #IVDR #NotifiedBody

In today's challenging deal environment, some #medtech companies are taking a solo path—launching their first medical devices independently, without traditional licensing or M&A. The challenge? Navigating complex regulatory pathways with limited experience. The solution? Partnering with high-quality contract development and manufacturing organizations (CDMOs). CDMOs provide expertise, specialized resources and advanced manufacturing capabilities to streamline the approval process and accelerate time to market. With cutting-edge technology and regulatory insights, they help mitigate risks and set companies up for successful launches. Learn more in our latest industry outlook: https://rsm.us/3VInsV4

Streamline Your EU Medical Device Registration with Precision and Ease Navigating the EU registration process for medical devices can be complex, but with our expertise, you’ll have everything you need to move forward with confidence and efficiency. Our consultancy services are dedicated to equipping clients with meticulously crafted document templates tailored for each critical stage of the registration process. We specialize in delivering essential tools—including Risk Assessments, Protocols, Reports, and Checklists—all designed to meet the unique needs of your device and regulatory pathway. Each template is not only fully compliant with EU regulations but also customized to ensure that your team can execute every step smoothly, reducing time and minimizing errors. Key Benefits of Our Services: Customized Templates: Receive document templates that reflect your device’s specific requirements, giving you a clear advantage in the registration process. Regulatory Compliance: Our templates are designed in line with EU standards, ensuring that your documentation is audit-ready and fully compliant. Time Efficiency: With our comprehensive templates, your team can move through each stage of registration more quickly, minimizing delays. Expert Guidance: We don’t just provide templates; we offer expert insights and best practices to support your team’s success at every stage. If you’re ready to streamline your EU registration process with customized, compliant, and efficient document templates, let’s discuss how we can make your journey to market faster and smoother. Contact us today to learn more and start your path toward hassle-free EU compliance! ______________________________________________________________ All our Services: https://lnkd.in/eVXf7WPw #pharma #medtech #biotech #gmp #zamann

National authorities in Member States have endorsed a new strategy for the #COMBINE programme, a cross-sector initiative to streamline combined studies of #medicines and #medicaldevices, including #diagnostics. The COMBINE initiative aims to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and to identify possible solutions and consists of two phases:  - analysis of the challenges at the interface of MDR/IVDR/CTR (including collecting and analysing the challenges reported by various actors involved, mapping relevant national processes and already ongoing work) - possible development of solutions that aim to address some of the challenges. The programme will roll out 7 cross-sector projects over the coming years including: - the pilotage of a single assessment process for multi-country combined studies under device and #medicinalproduct regulations. - the harmonisation of serious #adverseevents reporting processes. - the clarification of the interface between #clinicaltrials and medical device regulations. - the introduction of new ways to advise sponsors and enabling knowledge exchange among #nationalauthorities. Read more: https://lnkd.in/drq5iMH5 #medtech #biotech #pharma #medtechnews #biotechnews #pharmanews

US FDA News!! (De Novo eSTAR) The FDA has today released final guidance on 'Electronic Submission Template for Medical Device De Novo Requests' This final guidance describes the technical standards associated with preparation of the electronic submission template for De Novo classification requests that enable submission of the De Novo electronic submission solely in electronic format. The electronic submission template includes the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary elements of a ‘complete’ submission. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #machinelearning #estar #denovo

Monitor the whole lifecycle of your devices with BPAMedical365® to ensure patient safety, https://lnkd.in/e7yDVY7R The #MedicalDevice Lifecycle – Overview and #Automation Potential, https://lnkd.in/dbFNhEki #medtech #iso13485 #qms #patientsafety #qualitycontrol #fda #mdr #pharma #gxp #gmp #compliance #regulatoryaffairs