ISO 13485 Medical Devices | Industry Sectors

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 NANDO information 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.

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.

Have you got your copy of the latest white papers?

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 make sure they fully understand the requirements.

Download your copy now

Recent advancements in AI - implications for medical device technology and certification

This white paper provides a very brief overview of where AI is being used in healthcare, and why it might be increasingly seen in medical devices. We also consider what specific additional requirements this might place on regulatory requirements in the near future.

Download your copy now

Welcome to BSI Medical Devices

Welcome to BSI Medical Devices

Revisions

BSI Transitions

Transfer to BSI

Recruitment opportunities

Compliance Navigator management tool

Supporting your medical device business

Welcome to BSI Medical Devices

Welcome to BSI Medical Devices

Revisions

BSI Transitions

Transfer to BSI

Recruitment opportunities

Compliance Navigator management tool

Supporting your medical device business

BSI achieves double designations

Our commitment to excellence

Support throughout the product lifecycle