📣 Medical Device Software under the MDR – Perspectives from a Notified Body 📣 This insightful webinar will introduce the important aspects of the Technical Documentation and typical gaps we see as a Notified Body for software applications applying for MDR certification. Our speaker, Thomas Doerge, Global Head AIMD and SaMD will provide an overview of the Medical Device Regulation requirements for software including GSPRs, applicable guidance, lessons learnt and the interplay between AI and the MDR. Register now! 25 March 2025 | 09:00 and 16:00 GMT https://bit.ly/3FoRrfG #BSI #MedicalDevices #SaMD
BSI Medical Devices
Medical Equipment Manufacturing
London, Greater London 74,476 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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Navigating the intersection of AI regulations and medical device requirements is crucial for manufacturers. Our latest whitepaper, developed by AI Regulatory Leads and the Head of AI Notified Body at BSI, provides key insights on how the EU AI Act aligns with the EU Medical Devices Regulation (MDR). This comprehensive whitepaper outlines the steps manufacturers need to take to integrate AI-specific measures into their existing MDR processes, ensuring compliance and maintaining a competitive edge. Download the whitepaper now: https://bit.ly/4bM2ATC #EUAIAct #MDR #AICompliance #AI #AIAct #Whitepaper #ShapingTrustInAI #BSI
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ISO 13485 certification is critical for accessing regulated markets worldwide. Let us support your certification journey with proven expertise. Start the process today and expand your reach! Contact us today: https://bit.ly/4kxB40e #BSI #MedicalDevices #ISO13485 #QMS
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Our Orthopaedic and Dental Team has just released a new brochure. Check out the O&D dedicated webpage to discover more: https://bit.ly/3XG9Nik #BSI #MedicalDevices #Orthopaedic #Dental
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BSI is continuously committed to providing manufacturers with efficient pathways to place medical devices on the market. Since January, our Active Devices Team lead times and our General Devices lead times for ophthalmic devices have both decreased by one month. We continue to accept applications for MDR, IVDR, and UKCA without restrictions, covering all device types. Find out more by visiting our dedicated webpage here: https://bit.ly/3QUTpXv #BSI #LeadTimes #MedicalDevices #IVD #NB #UKAB
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International Women’s Day 2025: A Time to Reflect, Recognize, and Raise Standards At BSI, International Women’s Day is not just a celebration; it’s a moment to reaffirm our commitment to fostering workplaces that empower and support both women and people who menstruate. One area where we’re driving meaningful change is through BS 30416, a groundbreaking workplace standard addressing menstruation, menstrual health, and menopause. This guidance helps organizations prioritize employee well-being by building supportive, inclusive environments where everyone can thrive. The impact of this standard is already being felt. From improving productivity to reducing absenteeism, organizations are seeing tangible benefits while breaking taboos and normalizing open conversations about these often-overlooked topics. This International Women’s Day, we encourage all organizations to take a closer look at their workplace culture. How are you supporting your colleagues’ health, well-being, and dignity? 🔗 Learn more about BS 30416 and how it’s shaping best practices: https://bit.ly/43kTAmk #BSI #MedicalDevices #IWD2025 #InternationalWomensDay #BSI
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📣 How to prepare for the new Post-market Surveillance Requirements in Great Britain 📣 This insightful webinar will introduce the PMS requirements under the new regulations in Great Britain for Post-market Surveillance. Our speakers, Jenifer Hannon, MTOPRA, Post Market Surveillance Regulatory Lead and Vishal Thakker, Head of UK Approved Body will provide an overview of the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR. Register now! 25 March 2025 | 09:00 and 16:00 GMT https://bit.ly/41sDKER #BSI #MedicalDevices #PostMarketSurveillance
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Is your business ISO 13485-certified? Our experts can support your ISO 13485 compliance journey ensuring your devices meet global standards. Stay ahead with BSI’s expert services—because the future demands quality and innovation. Download our FAQs to learn more: https://bit.ly/3QHktte #BSI #MedicalDevices #ISO13485 #QMS
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📣 Medical Device Software under the MDR – Perspectives from a Notified Body 📣 As a manufacturer of a Software as a Medical Device (SaMD), you must ensure that you meet the relevant regulatory requirements before placing your product onto the market. It is critical to work with a trusted EU Notified Body or UK Approved Body. Join this webinar as we discuss the Medical Device Regulation requirements for Software including GSPRs, applicable guidance, lessons learnt and the interplay between AI and the MDR. Secure your spot today: 27 March 2025 | 09:00 and 16:00 GMT https://bit.ly/43ljsyn #BSI #MedicalDevices #SaMD
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Check out our new leaflet on nanomaterials and nanotechnology. Learn more on their application in the medical devices industry and access state of the art guidance. https://bit.ly/41DhgRD #BSI #MedicalDevices #Nanomaterials #Nanotechnology