TEAM-PRRC

🎬 TEAM-PRRC Annual Summit 3rd edition Event Highlights: Màlaga in video 🎬   Relive the energy, the learning, and the connections we built together!   What an incredible experience we had in Màlaga! Thank you to everyone who joined us — our attendees, speakers, and sponsors — for making this event a success. From insightful sessions on regulatory intelligence to invaluable networking moments, it was a pleasure to connect with such passionate professionals in the MedTech industry.   This journey doesn’t end here; stay tuned for our next summit in Rome (Italy) as we continue empowering regulatory excellence.   #PRRC #MDR #IVDR #MedTech #medicaldevice #RegulatoryAffairs #EventRecap #ThankYou

📊 Survey Results Are In! 📊 As promised, we share the insights from our latest survey conducted on the role of the Person Responsible for Regulatory Compliance (PRRC) launched last month. This survey captured key data on PRRCs’ challenges and responsibilities in regulatory compliance in Medtech industry. Thank you to the 150 persons who participated and shared valuable feedback! These insights help us shape resources and events that support the PRRC community’s needs. Stay tuned as we continue to deepen our understanding of the PRRC role and its critical impact on the MedTech sector. #PRRC #RegulatoryCompliance #MedTech #SurveyResults

🌐 Upcoming Webinar Alert! 🌐 Join us for an insightful webinar on "How to Build Effective Regulatory Intelligence and Impact Assessments for PRRCs", led by Ivan Perez Chamorro, CEO of MedBoard. Discover practical strategies, tools, and industry insights to enhance your regulatory expertise and stay compliant in an ever-evolving landscape. The webinar is free of charge and open to all. 🗓 Date: November 19th, 2024 ⏰ Time: 5.00 pm CET 📍 Location: Online Webinar 🔗 To register click here: https://lnkd.in/eX3U6zvu Whether you are a PRRC, a regulatory affairs professional, or simply looking to expand your knowledge, this session will equip you with actionable steps to strengthen your regulatory intelligence approach and streamline impact assessments. Don't miss this webinar ! #MDR #IVDR #PRRC #medicaldevice #regulation #intelligence #medtech #regulatoryaffairs #quality #webinar

✨ Thank You all for Making the TEAM-PRRC Annual Summit a Success! ✨ As our summit comes to a close, I would like to extend my deepest gratitude to everyone who contributed to this incredible event. 🌟 A special thank you to our amazing Board (Bassil Akra, Anne Jury and Jean-Louis DIVOUX), who are each of them my precious support. 🌟 To our attendees, your active participation made every session more dynamic. 🌟 To our expert speakers, thank you for sharing your knowledge and insights: • Orla Daly – Policy and Legal Officer, MDCG  • Carmen Ruiz-Villar Fernandez-Bravo – Deputy Director, AEMPS • Francoise Schlemmer – Director, Team-NB • Merlin Rietschel – Senior Manager, MedTech Europe  • Christopher Kipp – Referent/Manager Regulatory Affairs, BVMed  • María Diez Zaera – Quality Manager & PRRC, LEGIT.HEALTH  • Taig Mac Carthy - COO, LEGIT.HEALTH • Àngels Roma – VP Quality & Regulatory Affairs, WERFEN  • Markus Pöttker – Director Global PMS, Smith+Nephew • Diana Berriozábal – PRRC, ATRAMAT  • Dr. Ceren A. – PRRC, Freyr Solutions  • Martin Coles – External PRRC, International Associates Ltd  • Mika Reinikainen – Chairman, UKRPA • Eric Klasen – TEAM-PRRC Swiss Representative  • Ajda Mihelčič – Regulatory Intelligence & Innovation Manager, OBELIS Group  • Alex Laan – Head of IVD Notified Body, BSI • Marta Carnielli – Head of Certification IVD, TÜV SUD • Tom Patten – IVDR/IVD International Manager, GMED • María Teresa Gómez Manzano – MD Manager & Lead Auditor, SGS  • Julia Caro – Head of Technical Area, Centro Nacional de Certificacion de Productos Sanitarios • Marta de Oliveira Ferreira – CEO, INOVAPOTEK  • Erik Vollebregt – Partner at Axon Lawyers • Sandra Ferretti – Lead Representative PRRC  • Carmen Martin – TEAM-PRRC Representative for Spain 🌟 To our sponsors, your support is important. • Regulatory Affairs Professionals Society (RAPS)  • MedBoard  • CMG MedDev • IVDeology Ltd • TraceX • Ronald Boumans consulting  • AbroadLink Traductions Together, we have created something truly special. Success comes from helping each other, and this summit reminded us that together, we go further. We look forward to welcoming you all next year in beautiful Rome for another inspiring event! 🇮🇹 Let’s continue to grow and strengthen our community. See you in 2025! #TEAMPRRC #Summit2024 #MDR #IVDR #medicaldevice #MedTech #Patientsafety #TogetherWeGoFurther #Rome2025

Very happy to have been involved in the 3rd Annual Summit of TEAM-PRRC here in sunny Málaga. We heard from representatives of all interested parties from the MDCG, Spanish competent authority and five different notified bodies to manufacturers and PRRCs within MD and IVD manufacturers, authorised representatives and external PRRCs. One key point is a clear understanding across all parties that the PRRC does not carry any personal liability for defective product. As Erik Vollebregt put it, the PRRC is responsible for ensuring that certain processes are followed, NOT that those processes have a certain outcome. Join us as a member at https://lnkd.in/eT9qSz87 and contribute to the content of our next summit in October 2025 in Rome! #PRRC #MDR #IVDR #complianttogether

Yesterday, the annual TEAM-PRRC Summit ended successfully in #Malaga. It was a great event with many positive feedback on the relevance and importance of the topics that were presented and discussed. I would like to say thank you to everyone who supported this event being such a success. A big thanks to Orla Daly from the EU Commission and Carmen Ruiz-Villar Fernandez-Bravo from the Spanish National Authority for their support to this educational event. We are looking forward to seeing you next year in October in #Rome 🇮🇹 Elem AYNE Anne Jury Jean-Louis DIVOUX

📢 The Third TEAM-PRRC Annual Summit Has Officially Concluded !! After two days of insightful discussions, networking, and learning, we are bringing the third edition of the TEAM-PRRC Annual Summit to a close. In the closing meeting, the Board of TEAM-PRRC expressed their sincere thanks to all the attendees, speakers, and sponsors who contributed to the event’s success. We are also thrilled to announce that the next summit will take place in Rome (Italy) on October 23 & 24, 2025 – stay tuned for more details! Thank you for your active participation, and we look forward to seeing you at the next edition! #TEAMPRRC #MedTechCompliance #PRRC #SummitConclusion #NextSummit #RegulatoryAffairs #medicaldevice #MDR #IVDR

📢 Final Session of the TEAM-PRRC Annual Summit: Closing with Our Representatives Sandra Ferretti and Carmen Martin. Join us for the last presentation of this 3rd edition of TEAM-PRRC Annual Summit about a regional updates and differences between some National Laws. TEAM-PRRC continues to look for new Representatives. So if you are a PRRC living in a Member State that we don't cover, do not hesitate to contact us ! #TEAMPRRC #MedTechCompliance #PRRC #RegulatoryAffairs #MDR #IVDR #sanctions #regulation #safety #compliance #medicaldevices

📢 New Session: PRRC Liability – Does the PRRC need an Insurance? presented by Erik Vollebregt from Axon Lawyers. Important session at the TEAM-PRRC Annual Summit on PRRC liability, featuring a well-known lawyer in the medtech sector. Within TEAM-PRRC, we received so many questions about liability and insurance, and we thank a lot Erik Vollebregt to have accepted our invitation and tell us more about: - The legal responsibilities of PRRCs under EU MDR/IVDR. - The risks PRRCs face in their role. - Whether PRRCs should consider obtaining professional liability insurance. This is a must-attend for any PRRC looking to understand their legal obligations and safeguard their career! #TEAMPRRC #MedTechCompliance #PRRC #Liability #RegulatoryAffairs #LegalRisks #Insurance #MDR #IVDR

📢 New Session: Clinical Investigation with inovapotek – What is The Role Played by PRRC? presented by Marta de Oliveira Ferreira Now we have a presentation where Marta will tell us more about clinical investigations, and if the PRRC has a critical role on that topic. This session will provide invaluable insights into the responsibilities of PRRCs in the context of clinical research! #TEAMPRRC #MedTechCompliance #ClinicalInvestigations #RegulatoryAffairs #PRRC #MedicalDevices #MDR #IVDR #MedTech #safety #performance