BSI, a leading Notified Body, has a worldwide reputation for providing services that blends experience with safety and speed with predictability. Whether your product is simple or complex, BSI is committed to delivering professional, robust, fast and responsive IVD CE marking and ISO 13485 Quality Management services.
· Combined Industry and Regulatory In-house Expertise in Wide-Range IVD Products
· Predictable, Fast, Efficient and Professional Service
· Speed-to-Market Programs
· Full Scope in all 3 CE marking Medical Device Directives
· Understanding of how to Navigate the Regulatory Landscape
· Making the Transfer Process Timely and Seamless
· Responsiveness and Easy Access to In-house Expertise
· Use Industry Leaders for our Batch Testing
BSI has an outstanding team of in- house experts with an average of 17 years IVD industry and regulatory experience in a wide-range of products. These leading experts have worked on all aspects of the product life cycle including R&D, manufacturing and quality to meet the demands of this exciting marketplace—both now and in the future. Our streamlined structure enables you to have one person to contact that understands your business, can answer your questions quickly and optimize the process in getting your IVD device to European markets.
Batch TestingBSI works with two of the world-leading test laboratories, Paul Ehrlich Institute in Germany and Sanquin in the Netherlands to provide Annex II List A Verification of Manufactured Product testing. Companies using these laboratories that choose to transfer to BSI can keep their same testing facilities—this will enable a smoother and more seamless transition.