Medical Devices

Medical Devices

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ISO 13485:2016
ISO 13485:2016
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Does your medical device business deliver excellence?

We ensure patient safety while supporting timely market access for our clients Medical Device products globally. Experience thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and accepted worldwide.

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

Product lifecycle supoprt

Product lifecycleRegardless of which phase of the product lifecycle you’re in, BSI can work with you to minimize your corporate risk and ensure you remain compliant. Talk to us early to take advantage of our full range of services.

Understand the product lifecycle >

Committed to excellence

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

BSI Medical Devices successes of 2019 and the year ahead

BSI Netherlands Successfully Achieves Designation as a Medical Device Notified Body

Netherlands flagBSI is delighted to formally announce our successful designation under the existing 3 Medical Device Directives (MDD/AIMDD and IVDD) in the Netherlands. This firmly anchors BSI's presence as a Medical Devices Notified Body irrespective of the BREXIT outcome.

Find out more >

Post-Brexit update on the validity of CE certificates issued by our UK Notified Body (0086)

Following the official announcement on Friday 31 January 2020 that the UK has officially ceased to be a member of the European Union, the UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. What does this mean for medical device manufacturers?

Read our latest update >