ISO 13485 after brexit
Read the news article to learn more about the validity of accredited management system certificates issued by UK based conformity assessment bodies following the UK's departure from the EU.
Given the stringent requirements on patient safety and device performance, accessing the European market brings challenges that can delay your product launch. It is critical to work with a Notified Body that understands the industry and has the experience to review and confirm your product’s readiness for market.
BSI The Netherlands (2797) is a leading Notified Body achieving full-scope designation under MDR and IVDR. We review your medical devices and IVDs to assess conformity against European Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to market.
Full range of certification services for all medical devices
The certification process for the MDR and IVDR
MDR Conformity Assessment Routes
We offer a range of training courses to help you with CE marking