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CE Marking for medical devices CE Marking is the medical device manufacturer’s claim that a product meets the essential requirements. Find out more >
CE Marking for IVD devices BSI is committed to ensuring a smooth transition for all clients wishing to certify to the IVDR. Find out more >
Quality Management System ISO 13485 ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. Find out more >
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Compliance Navigator management tool Manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements. Find out more >
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Does your medical device business deliver excellence? We ensure patient safety while supporting timely market access for our clients Medical Device products globally. Experience thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and accepted worldwide. BSI Medical Devices offers certification services to support your global market access goals. We are: A designated European Notified Body An accredited ISO 13485 Certification Body A recognized Auditing Organization under the Medical Device Single Audit Program, MDSAP A recognized Certification Body in many global markets
Product lifecycle supoprt Regardless of which phase of the product lifecycle you’re in, BSI can work with you to minimize your corporate risk and ensure you remain compliant. Talk to us early to take advantage of our full range of services. Understand the product lifecycle >
Committed to excellence Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge. We demonstrate this commitment through: Over 2,050 years’ medical device product and regulatory experience Internal Product Experts and Auditors Direct access to your team of technical specialists Our range of review services to give you flexibility
BSI Medical devices and the impact of COVID-19 on audits As the coronavirus COVID-19 outbreak evolves, the safety and wellbeing of our clients and colleagues is our highest priority, so please read our latest updates on how we are managing global audits and assessments. Read our latest update >
BSI Netherlands Successfully Achieves Designation as a Medical Device Notified Body BSI is delighted to formally announce our successful designation under the existing 3 Medical Device Directives (MDD/AIMDD and IVDD) in the Netherlands. This firmly anchors BSI's presence as a Medical Devices Notified Body irrespective of the BREXIT outcome. Find out more >
Post-Brexit update on the validity of CE certificates issued by our UK Notified Body (0086) Following the official announcement on Friday 31 January 2020 that the UK has officially ceased to be a member of the European Union, the UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. What does this mean for medical device manufacturers? Read our latest update >
