BSI Medical Devices

Talk to us: https://bit.ly/3KDhRg9 BSI Structured Dialogue offers manufacturers an opportunity to better understand the Notified Body conformity assessment processes for medical devices and IVDs. It may address procedural aspects of pre-application and application processes, Notified Body assessment procedures, high-level aspects of manufacturer’s evidence of conformity or more complex combinations of clinical, technical, and regulatory conformity approaches while maintaining the impartiality of the Notified Body. Visit our webpage here: https://bit.ly/485CXO2 #BSI #MedicalDevices #IVDs #StructuredDialogue

BSI is continuously committed to providing manufacturers with efficient pathways to place medical devices on the market. Our General Devices lead times for wound care and ophthalmic devices have decreased by one month. We continue to accept applications for MDR, IVDR, and UKCA without restrictions, covering all device types. Talk to us: https://bit.ly/47l1AoW Find out more by visiting our dedicated webpage here: https://bit.ly/4qpRBpQ #BSI #LeadTimes #MedicalDevices #IVD #NB #UKAB

🚀 Launching the BSI Insight Series: Startup Edition! A new webinar series to help startups & small manufacturers fast-track growth through smart quality management & EU device certification. 🎯 First up: Roadmap to Market Access Get clarity on EU MDR, IVDR, ISO 13485 & MDSAP - and how to navigate compliance from documentation to post-market obligations. 🗓️ Register now for the first webinar + full series: 👉 https://bit.ly/4qsiNog #BSI #MedicalDevices #Webinar #Startups #BSIInsightSeries

Still Time to Register: Free Webinar – How to Streamline Your MDR or IVDR Review Don’t miss your chance to attend this free, expert-led webinar designed to help you navigate the complexities of MDR and IVDR certification with greater confidence. Our speakers will share how Dedicated Interactive Reviews can streamline your path to compliance - whether you're submitting a new application, transferring, or undergoing surveillance. This session is ideal for: • Manufacturers of medical devices and IVDs working with BSI for MDR, IVDR, or UKCA • Quality professionals seeking a deeper understanding of Dedicated Interactive Reviews Gain actionable insights into the certification process and how to avoid common delays in technical and clinical reviews. 👉 Register now to secure your spot and take a critical step toward certification success! https://bit.ly/489lmEX #BSI #MedicalDevices #StructuredDialogue #Webinar

Meet BSI Around the World – October 2025 Events! This October, we’re excited to be joining key international events around the world! Connect with our experts for more insights into AI, Medical Devices, MDR compliance, and IVDR developments shaping the industry. 📅 EFGCP Better Medicines for Children 2025 (Oct 21 - 22): Don't miss our speaker Richard Holborow, BSI Head of Clinical Compliance, for the session on Paediatric medical devices 📅 MD&M Midwest (Oct 21-22): Don’t miss the chance to connect with our other experts at the booth 2928 for more regulatory updates 📅 MTAA MedTech Conference 2025 (Oct 22-23): Mark your calendar for BSI’s speaking engagement, featuring presentations from Dushyant Sanathara, BSI AI Commercial Operations Director on the topic "AI Governance: A Framework in Implementing AI Safely" 📅 TEAM-PRRC Annual Summit (Oct 23-24): Our leading regulatory experts Breda Kearney will present on topic "PMS & vigilance: ensuring compliance" 📅 2025 European Lifecycle Management (Oct 28-29): Join our expert, Richard Holborow, BSI’s Head of Clinical Compliance, as he shares the latest insights in his session “Are Words Mightier Than Numbers? Benefit-Risk Evaluations in Focus.” Richard will also feature as a panelist in the closing plenary at this key conference, organized by RAPS We’re excited to see you at these incredible events! Stay informed on the latest trends, connect with professionals, and gain insights from industry experts: https://bit.ly/3WhCkKe #BSI #MedicalDevices #RegulatoryServices #Events #Networking

Join us at the American Medical Device Summit in Chicago to connect with our team and see how BSI Compliance Navigator can simplify your regulatory compliance. Book a meeting in advance for a run-through of the platform, tailored to your needs. You can also visit our exhibition stand throughout the event to chat with our experts, ask questions, and discover how we help medical device manufacturers stay compliant, organised, and audit-ready. Schedule a meeting: https://bit.ly/4mWVi3C #bsicompliancenavigator #americanmedicaldevicesummit #regulatoryintelligence

Do you know that most common reasons for delays in technical documentation reviews are incomplete submission and poor documentation structuring? Our IVDR Documentation Submission Best Practice Guidelines help you in understanding what is required from a Notified Body perspective and in preparing a robust and complete technical documentation for your submission. A new section on IVDs incorporating AI and Machine Learning is also now included. Request a quote today: https://bit.ly/47hQykp Access the guidelines: https://bit.ly/4hexBm3 #BSI #IVD #IVDR #TechnicalDocumentation

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. Our Technical Specialists bring a wealth of experience in SaMD and are here to help you navigate the certification process for your device. Talk to us: https://bit.ly/3WG6hUb To find out more, visit our dedicated webpage: https://bit.ly/3JdosO5 #BSI #MedicalDevices #SaMD #Compliance #MDR #IVDR

Request BSI Structured Dialogue today: https://bit.ly/3KDhRg9 Hear from Teleflex Incorporated on their experience with BSI Structured Dialogue. Visit our webpage here: https://bit.ly/485CXO2 #BSI #MedicalDevices #StructuredDialogue #TeleflexIncorporated

BSI is proud to participate as a speaker and knowledge partner at the AMMI Malaysia MedTech Industry Summit. Our Scheme Manager & Technical Specialist, Leon Yang, from the Global Orthopaedic & Dental Technical Team, shared valuable insights on the topic: “EU MDR Unannounced Audit – What to Expect?” It was a great session with engaging questions from the audience - a true reflection of the industry’s commitment to compliance and quality. We’re glad to share our expertise and contribute to advancing knowledge within Malaysia’s MedTech community. #BSI #MedicalDevices #MedTech #EUMDR #KnowledgeSharing #AMMI