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ISO 13485 Quality Management The world’s most popular standard for medical devices quality management has been revised for the first time since 2003. Find out more >
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Why choose BSI as your notified body? Product expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies. Global access – we operate in over 180 countries with more than 100 years of experience and offices around the world to serve you. Speed-to-market – providing flexible solutions for manufacturers needing accelerated pathways to global markets. Confidence – our stringent review process combines speed with experience, integrity, independence and predictability. Experience – our team has over 1750 years’ combined industry and regulatory experience, so we understand the challenges you face.
