BSI Medical Devices

From all of us in the BSI Medical Devices team, we would like to wish you a very happy and festive holiday and a prosperous new year. The team will be taking a break from social media as of today and during the festive period. We will be back with new content in early January. Thank you to all our wonderful followers. #BSI #Medicaldevices #Happyholidays

As we draw to the end of 2024, Dr Manuela Gazzard, President, BSI Regulatory Services, reflects on some of our key achievements: “We are proud of the organisational changes introduced, to serve our clients and stakeholders more holistically. All conformity assessment services are now within one global division, including the new EU Artificial Intelligence act adopted on 13 March 2024. “Through these changes we are more streamlined, and able to conformity assess products in need of several compliance schemes. “Going into 2025, we are committed to serve you at the forefront of innovation, working together as we navigate the challenges and opportunities in a dynamic regulatory environment. “Thank you for your continued trust and partnership. “On behalf of my colleagues, I wish you, your loved ones a healthy and happy New Year”. #BSI #Medicaldevices #endofyear #Achievements #2024

BSI has been offering Structured Dialogue for over 20 years while fully respecting the independence and impartiality of the Notified Body. Whether you’re looking to discuss high-level aspects of evidence of conformity, Notified Body assessment procedures, QMS requirements, or more complex combination of clinical, technical, and regulatory conformity approaches, request Structured Dialogue with BSI today. Visit our webpage: https://bit.ly/49rYlM4 #BSI #MedicalDevices #StructuredDialogue

BSI has been offering Structured Dialogue for over 20 years to enhance the efficiency and predictability of the conformity journey through all its phases, while fully respecting the independence and impartiality of the Notified Body. Whether you’re a start-up, an SME or a well-established manufacturer, get in touch to discover how BSI Structure Dialogue can fit your conformity journey. Download the brochure: https://bit.ly/4fhmZQY #BSI #MedicalDevices #StructuredDialogue

Register now for our ‘PFAS restrictions and their impact on Medical Devices’ webinar. Hear our subject matter experts Vishal Thakker, Head of UK Approved Body and Piero Trabucco, Principal Technical Specialist & Scheme Manager as they discuss the main challenges that medical device manufacturers are expected to face in the near future and the impact the PFAS restrictions may have on CE marking of their products. This webinar will provide manufacturers with an introduction on what the next steps may be for manufacturers and how best to engage with the Notified Body. To register for one of the time slots below visit: https://bit.ly/3ZHEtkN Wednesday 29 January 2025 09:00 – 10:00 GMT Wednesday 29 January 2025 16:00 – 17:00 GMT #BSI #MedicalDevices #PFAS

BSI has been officially recognized by Raad voor Accreditatie (RvA) as an accredited certification body for the international standard on AI management systems, ISO/IEC 42001, as part of its ongoing commitment to building trust in AI! As an accredited certification body, we will provide certification services to ISO/IEC 42001, enabling organizations to benefit from our extensive expertise and robust certification process, ensuring their AI systems are developed and deployed in accordance with best practices and international standards around AI governance, risk management, and ethical considerations. Recognition as an accredited AI Management System Certification Body cements BSI’s commitment to advancing the development, implementation, and regulation of AI, and ensuring its alignment with globally recognized standards. Read more about this recognition and BSI's certification services here: https://bit.ly/3Zm9MjI #BSI #ArtificialIntelligence #AI #ISO42001

Are you an importer or distributor in the EU undertaking relabelling or repackaging activities for medical devices? Do you know that MDR and IVDR require you to get an Article 16(4) certification to demonstrate your QMS complies with the regulatory requirements for these activities? To know more, head over to our dedicated webpage: https://bit.ly/3OIHACA #BSI #MedicalDevices #Article16(4)

Safety is always going to be critical for any medical device. In the case of electrical devices, BS EN 60601-1:2006+A13:2024 defines how to prevent hazards and harms while ensuring devices perform as intended. The 2024 amendment ensures the standard continues to highlight the alignment with the latest medical device regulations. Learn more: https://bit.ly/4fabLOc #BSEN60601 #MedicalDevices #MedicalDeviceSafety #ElectricalMedicalDevices #ElectricalSafety #Healthcare #BSIStandards

Are you involved in AI in the Medical Imaging Industry, or interested in how voluntary assessments of AI can help to prepare for full conformity assessments under the EU AI Act? Don’t hesitate to register for our upcoming webinar: AI Algorithm Auditing and Dataset Testing (AA&DT) for the Medical Imaging Industry! Join Sam Roberts, AI Technical Specialist and Team Manager, as you learn about the relationship of this voluntary assessment service to the full conformity assessments required under the EU AI Act, and the benefits that a voluntary assessment can offer — both to prepare for a full conformity assessment and verify AI performance. Choose from one of the time slots below via the following link: https://bit.ly/49pqFPg Thursday 16 January 2025 📅 09:00 – 10:00 GMT 📅 16:00 – 17:00 GMT #bsi #shapingtrustinai #ai #iso42001 #aims

Exciting news! We have now expanded our capacity for the Orthopaedic and Dental team. Contact us now! Click the link for more information: https://bit.ly/4ifoFwR #BSI #MedicalDevices #Orthopaedic #Dental