BSI Transitions

Learn about the MDR, IVDR, ISO 13485:2016 and MDSAP on our dedicated revisions pages.

Transfer to BSI

Transfer to BSI and start making excellence a habit in your business

Learn more about the transfer process

Recruitment opportunities

BSI is recruiting for medical device experts

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Supporting your medical device business

We ensure patient safety while supporting timely market access for our clients Medical Device products globally.

We provide our customers with thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and accepted worldwide.

Maintaining quality, delivering excellence

BSI Medical Devices offers certification services to support your global market access goals. We are:

A designated European Notified 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

Find out more about all of our services.

Use our resources as you plan for your transition

We have released TWO new white papers for you to download:

Technical Documentation and Medical Device Regulation

This white paper reviews the regulatory requirements for Technical Documentation under the new MDR, with focus on conformity assessment routes and post-market surveillance. Use this resource as you plan and implement your transition plan for the new Regulation.

Download your copy now

Nanomaterials

This white paper discusses the advent and use of nanomaterials in medical devices and explores the regulatory requirements for devices containing nanomaterials. With increasing focus and scrutiny under the new Regulation, manufacturers should consider the use of nanomaterials and make sure they fully understand the requirements.

Download your copy now

View all white papers

Our commitment to excellence

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.

We demonstrate this commitment through:

Over 2,050 years’ medical device product and regulatory experience
Internal Product Experts and Auditors
Direct access to your team of technical specialists
Our range of review services to give you flexibility

Support throughout the product lifecycle

Regardless of which phase of the product lifecycle you’re in, BSI can work with you to minimise your corporate risk and ensure you remain compliant.

Talk to us early to take advantage of our full range of services.

How BSI can support you through the product lifecycle
Transferring to BSI
Our expert teams
Additional guidance and other resources
Access medical device standards
Training with BSI