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.
Accessing the European market brings challenges that can lead to delays in your product launch. Such delays can be costly for the manufacturer, and for patients who require care. However, there are stringent requirements in place to ensure patient and user safety, as well as the performance of the device.
BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.
Technical Documentation reviews for CE Marking, the most efficient routes to market
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
BSI has a strong commitment to providing the most experienced and efficient routes to global markets. We understand the challenges of achieving market access efficiently and safely, meeting commercial goals and regulatory requirements. Our services have been developed to support manufacturers seeking timely market access without compromise. They combine efficiency with the integrity, independence, robust and thoroughness that you have come to expect from BSI.
We can provide the following CE marking services: