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:
Regardless 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.
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 and the impact of COVID-19 on audits
As the coronavirus COVID-19 outbreak evolves, the safety and wellbeing of our clients and colleagues is our highest priority, so please read our latest updates on how we are managing global audits and assessments.
BSI Medical Devices successes of 2019 and the year ahead
Netherlands designated as a Medical Device Notified Body
BSI 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.
Brexit update on CE certificates issued by UK Notified Body
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?