Medical Devices | BSI Canada

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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BSI is now accepting applications for MDR

We can confirm that BSI is now accepting applications under the MDR for our UK Notified Body (0086) from 3 June 2019.

BSI UK Notified Body (0086) will begin to process quote requests and schedule work over the coming months. BSI will provide conformity assessments to the full scope of the MDR. This service will focus on our existing UK (0086) and NL (2797) clients. For further details on BSI’s scope, please visit the NANDOinformation system.

Who can I contact for further information?
Please contact your Account Manager to initiate the quotation process. They will be able to answer your questions in the first instance, and we recommend you use the free material:

BSI has a dedicated resource for your MDR Transition
Listen to one of our free webinars or read through the BSI whitepapers

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.

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

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