BSI Regulatory Services (Medical Devices) Certification Business Policy

Our mission is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global standard in thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and trusted worldwide.

BSI Assurance UK Ltd, BSI Group The Netherlands B.V. and BSI Group America Inc. are third party accredited /recognized certification bodies (UKAS, RvA and MDSAP) that supply management systems assessment and certification. As such, we do not perform any physical work on our client's sites apart from auditing, product inspection, witness testing and report writing. When on-site, our staff are always accompanied by a member of our client's staff.

BSI Group, The Netherlands B.V. is also a full scope Medical Devices EU Notified Body (2797) and BSI Assurance UK Ltd is also a full scope Medical Devices UK Approved Body (0086). As an EU Notified Body and a UK approved Body, BSI is dedicated to providing rigorous independent regulatory and quality management reviews and product certifications for medical devices, active implantable medical devices and in vitro diagnostic device manufacturers around the world.

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