Watch chapter 3 of our Guide to Conformity Series – CE marking. Stay tuned for the upcoming chapters. To know more, visit our dedicated webpage: https://bit.ly/4eGlYlq #BSI #MedicalDevices #GuidetoConformity #CEMarking
BSI Medical Devices
Medical Equipment Manufacturing
London, Greater London 72,812 followers
Your source of the latest news and developments in the medical device industry
About us
Our mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner. We strive to set the global standard through conducting impartial, responsive, robust and thorough conformity assessments, evaluations and certifications that are recognized and trusted worldwide.
- Website
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http://bit.ly/bsimeddev
External link for BSI Medical Devices
- Industry
- Medical Equipment Manufacturing
- Company size
- 5,001-10,000 employees
- Headquarters
- London, Greater London
- Founded
- 1901
Updates
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BSI Medical Devices reposted this
Listen back to our ‘Rollout of EU Reference Laboratories for IVDR Class D devices’ webinar, presented by Alex Laan, Head of Notified Body – IVD, Sara Fabi, Regulatory Lead – IVD. The webinar presents further insights in the newly enrolled EURL regulation. Class D IVD manufacturers will be better prepared for the engagement with BSI and the EURLs. Access the recording and slides here: https://bit.ly/3N1tI5H #BSI #IVD #IVDR #RegulatoryCompliance #EURLs
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As part of BSI’s commitment to ensuring patient safety while supporting timely market access to global medical device technologies, we are pleased to inform you that we are expanding our Notified Body services to offer a new certification scheme for MDR and IVDR: Article 16(4) Certification. According to Article 16(4), importers and distributors performing relabelling and repackaging activities for devices already placed on the market require a certificate from a Notified Body to demonstrate that their QMS complies with the requirements specified in Article 16(3) of the regulations. Head over to our latest e-news to learn more: https://bit.ly/3ZBrWzB #BSI #MedicalDevices #Certification #Article16
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What’s inside our EU AI Act whitepaper? From understanding risk categories to navigating compliance, our whitepaper covers it all. Learn how to align your AI systems with the latest regulations, improve operational efficiency, and position your organization for success in an AI-driven world. Download now to explore these key insights: https://bit.ly/3Xy9s0o #BSI #euaiact #aicompliance #ai #aiact #whitepaper #shapingtrustinai
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The 26 September deadline for manufacturers to have signed a written agreement and to have completed the transfer of appropriate surveillance is here! Join Maddalena Pinsi, Senior Regulatory Lead & Associate Head of Medical Devices at BSI, as she walks you through our “Steps towards MDR transition” last episode. Stay tuned for upcoming guidance and visit our MDR dedicated webpage: https://bit.ly/3ZzIlEH #BSI #MedicalDevices #StepsTowardsMDRTransition
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Join us for the first of our ISO 42001 webinar series: Prepare for ISO 42001 – a framework for the management of AI. Led by Ali Moshayedi, AI Client Manager in the BSI AI Regulatory Services team, this session will delve into practical explanations of how you can align with the rapid advancement of AI technologies and ensure that you leverage these innovations responsibly and ethically. To register for one of the time slots below please visit: https://bit.ly/4df1L5b Thursday 24 October 2024 09:00 – 10:00 BST Thursday 24 October 2024 16:00 – 17:00 BST For more information on ISO 42001 follow BSI AI Regulatory Services. #bsi #shapingtrustinai #ai #iso42001 #aims
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MDR Annex XVI regulates products without an intended medical purpose, including devices used for aesthetic indications and dual use products. Read our dedicated whitepaper where Rachel Mead, Clinical Regulatory Lead and Ester Leoni, Global Regulatory Comms Manager, will walk you through Annex XVI regulatory framework. BSI is accepting Annex XVI applications. If you want to know more or want to discover how BSI can walk you through your compliance journey, access our dedicated resources here: https://bit.ly/4eAjx3W #BSI #MedicalDevices #MDR #AnnexXVI
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Excited to be part of the TOPRA Symposium 2024! Join us from Sept 30 - Oct 2 in Rotterdam as our leading experts share their insights on the latest developments in the regulatory landscape. Key sessions you won’t want to miss: • Unravelling AI as a Medical Device: Insights into the EU AI Act and Other Global Perspectives Alex Zaretsky, PhD, EMBA, Regulatory Lead - Artificial Intelligence • UK MDR: Current requirements and future perspectives for medical devices and invitro diagnostics Vishal Thakker, Head of UK Approved Body & Senior Regulatory Lead • Responsible and Experienced PRRC for MDR and IVDR Maddalena Pinsi, Associate Head of Medical Devices Notified Body and Senior Regulatory Lead Stop by booth 32 to learn more about BSI, a leading full-scope Notified Body and UK Approved Body! Register now: https://bit.ly/4ev1lI #BSI #MedicalDevices #TOPRASymposium
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The EU Commission released a survey on eIFUs for medical devices to gather feedback on the potential extension of (EU) 2021/2226 scope to all professional use devices. BSI encourages healthcare professionals and professionals working in healthcare institutions to take the survey. Your feedback is pivotal to support the decision-making process of EU medical device regulators. The survey will be available in all EU languages and will run until 11 October 2024. To take the survey click here: https://bit.ly/3MWxcGM #BSI #MedicalDevices #EUCommission #Survey #eIFU
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In March 2023, the Regulation (EU) 2023/607 amending the MDR was published in the OJEU with immediate effect. The 26 September deadline is fast approaching! We encourage you to read our Amending Regulation (EU) 2023/607 FAQs to find answers to most frequently asked questions on the MDR transition and associated topics. To know more visit our MDR dedicated webpage: https://bit.ly/4gt1yy9 #BSI #MedicalDevices #MDRTransition #FAQs