As BSI celebrates the World Health Organisation (WHO) Patient Safety Day on 17 September 2024, join us to learn more about our role as a Notified and Approved Body in the activities we perform to ensure patient safety in the devices we certify. Register now for our upcoming ‘BSI Notified/Approved Body & The Role It Plays In Patient Safety’ webinar. Our speaker Richard Holborow, Head of Clinical Compliance, will shed light on the regulatory systems in both the EU and UK. The webinar will be on 17 September 2024 at 16:00 BST only. Register now: https://bit.ly/3SMYF0K #BSI #MedicalDevices #WHOPatientSafetyDay #NotifiedBody #ApprovedBody
BSI Medical Devices
Medical Equipment Manufacturing
London, Greater London 72,481 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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According to Amending Regulation (EU) 2023/607, if you are transitioning your devices to the MDR, you will be able to benefit from extended validity of your directive certificates for placing legacy devices on the market (until the end of 2027/2028 based on the device classification), if certain conditions are met. Among these, as manufacturer you must sign an MDR formal agreement with a Notified Body by 26 September 2024 and, if applicable, by the same date, appropriate surveillance of MDD/AIMDD certified devices must be transferred to the Notified Body you signed the MDR agreement with. To know more visit our MDR dedicated webpage: https://bit.ly/4dAsx8C #BSI #MedicalDevices #MDRTransition #GuideToConformity
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Discover our new brochure on UKCA marking with BSI! This guide will take you through our certification process, from your application to BSI to the issuance of your UKCA Certificate. Visit our UKCA dedicated webpage to access additional resources: https://bit.ly/3WLB5mf #BSI #MedicalDevices #UKCA #UKCAmarking
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Register now for the ‘Rollout of EU Reference Laboratories for IVDR Class D devices’ webinar. Hear our subject matter experts Alex Laan, Head of Notified Body – IVD and Sara Fabi, Regulatory Lead – IVD, as they discuss the newly enrolled EURL regulation. Participants will gain a better understanding on the rollout of EURLs and will be better prepared for the engagement between BSI and the EURLs. Register now for one of the sessions below on Thursday 26 September 2024: https://bit.ly/46UZudE Thursday 26 September 2024 09:00 – 10:00 BST & 16.00 - 17.00 BST #IVD #IVDR #RegulatoryCompliance #EURLs
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As BSI celebrates the World Health Organisation (WHO) Patient Safety Day on 17 September 2024, join us to learn more about our role as a Notified and Approved Body in the activities we perform to ensure patient safety in the devices we certify. Register now for our upcoming ‘BSI Notified/Approved Body & The Role It Plays In Patient Safety’ webinar. Our speaker Richard Holborow, Head of Clinical Compliance, will shed light on the regulatory systems in both the EU and UK. The webinar will be on 17 September 2024 at 16:00 BST only. Register now: https://bit.ly/3SMYF0K #BSI #MedicalDevices #WHOPatientSafetyDay #NotifiedBody #ApprovedBody
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Hear from Paula Gomes, Global Head of Active Medical Devices about how our specialized knowledge can guide you through the certification process. Our team is dedicated to support you every step of the way. To learn more on Annex XVI visit our dedicated webpage for further guidance: https://bit.ly/3ybr0Hb #BSI #MedicalDevices #AnnexXVI
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The Vascular team is excited about the opportunity to work with both our established and new clients to ensure patient safety while supporting timely market access. Our technical and clinical specialists have significant experience in a wide range of vascular devices and are ready to meet with you and discuss your specific needs. Whether it is a new technology, well-established standard of care device, or anywhere in between, our team is ready to engage with you to understand your devices, provide our conformity assessments, and support bringing these lifesaving technologies to market. For more information, please visit our dedicated webpage: https://bit.ly/4djytDd #BSI #MedicalDevices #Vascular
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Register now for our ‘BSI Notified/Approved Body & The Role It Plays In Patient Safety’ webinar. Hear our subject matter expert Richard Holborow, Head of Clinical Compliance, discuss the role BSI as a Notified and Approved Body plays in ensuring patient safety. Participants will gain a better understanding of the regulatory systems in both the EU and UK and how patients and medical professionals can help play their part in supporting safe and effective devices on the market. The webinar will be on 17 September 2024 at 16:00 BST only. Register now: https://bit.ly/3SMYF0K #BSI #MedicalDevices #WHOPatientSafetyDay #NotifiedBody #ApprovedBody
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Hear from Nick Trilokekar, Technical Team Manager, General Devices, about how our specialized knowledge can guide you through the certification process. Our team is dedicated to support you every step of the way. To learn more on Annex XVI visit our dedicated webpage for further guidance: https://bit.ly/3ybr0Hb #BSI #MedicalDevices #AnnexXVI
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Register now for our “Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits” webinar. Hear our subject matter experts Alex Laan, Head of Notified Body – IVD and Sara Fabi, Regulatory Lead, Notified Body – IVD, discuss definitions of IVD kits, accessories, components, and procedure packs. Participants will gain an understanding of qualification and classification as well as regulatory requirements of IVD kits as we discuss product configurations and potential certification scenarios. To register choose one of the time slots below: https://bit.ly/3WEFHMi Tuesday 10 September 2024 09:00 – 10:00 BST Tuesday 10 September 2024 16:00 – 17:00 BST #BSI #IVDR #IVDKits #RegulatoryCompliance
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