The challenges medical device manufacturers face in today’s highly competitive marketplace make it essential that your product meets all regulatory and quality requirements before launch. It’s critical to work with a partner who understands the industry and has the depth of experience to review and confirm the products’ readiness for market – efficiently, reliably and promptly.

BSI provides rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too.

In the race to get new medical devices to market, speed is a crucial component. BSI has a strong commitment to providing a fast and experienced route to global markets. This adds up to the kind of speed-to-market you need if you want to stay competitive, or more importantly, move ahead of the competition.

Our programmes have been developed especially for medical devices needing Technical File and Design Dossier Reviews. They combine speed-to-market with the integrity, independence, predictability and the thoroughness you’d expect from BSI.

We have specialized experience in complex high-risk products requiring Design Dossier Reviews including active, animal tissue, drug device combination, implantable, invasive and novel medical devices.

• Product expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies.
• Global access – we operate in over 150 countries with more than 100 years’ 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.
• Partnership – we work on a partnership approach offering a wide range of proven regulatory and quality management programmes that work together to deliver full international compliance.