Regulatory Services

How We Work With Our Medical Device Clients

BSI works with many of the largest medical device companies in the world.

What We Offer You

Maintaining quality and delivering excellence, BSI offers certification services to place safe and compliant medical devices on the market.

A designated EU Notified Body
A UK Approved Body
An accredited ISO 13485 Certification Body
A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP)
A recognized Certification Body in many global markets

Regulatory Services

Our regulatory services combined with our world-leading experience provide efficient pathways to place your device on the market.

Structured Dialogue offers manufacturers an opportunity to better understand the Notified Body conformity assessment processes for medical devices and IVDs. It's different from scientific advice, excludes the Notified Body providing solutions to the manufacturer and does not have any impact on future certification decisions for the device under application.

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We offer a wide range of resources to support SME's by increasing their knowledge on key regulatory topics for market readiness.

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Discover how we can support your compliance journey through our regulatory services portfolio.

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BSI provides experienced and efficient routes to global markets.

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We can offer a seamless service with comprehensive support and the absolute minimum level of disruption.

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