A world class service for medical device manufacturers

ISO 13485 2016 Medical Devices

The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.

We understand the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.

BSI is a leading business services provider for organizations worldwide, offering a range of services in management system certification such as ISO 13485, product testing and certification, and standardization. Our service philosophy is focused on robust and timely reviews, making us a trusted industry regulator. 

Our Services

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Why choose BSI?

  • 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 programs that work together to deliver full international compliance

Medical devices training courses

Our ISO 13485, ISO 14971 and CE Marking training will help you demonstrate your ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.

The best way to get your products to market

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 path 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 programs 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.  

Specializing in high-risk products

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.