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.
CE Marking for medical devices
CE Marking for medical devices
European market access with a trusted CE Marking Notified Body
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.
CE marking resources to support you
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Brochure: download to learn about routes to CE marking >Technical Documentation reviews for CE Marking, the most efficient routes to market
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Brochure: download now >The certification process for the MDR and IVDR
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Webinar: watch on demand >MDR Conformity Assessment Routes
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Training: book now >We offer a range of training courses to help you with CE marking
CE-Excellence: Technical Documentation review services
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:
The BSI CE-Standard review service allows you to work closely with your assigned BSI Product Expert on your product certification. These reviews are conducted remotely, with communication between you and your BSI Product Expert via phone and email, as required.
The BSI CE-Dedicated review service allows you to schedule your Technical Documentation review with a dedicated BSI Product Expert. The review is conducted remotely via teleconferencing, allowing you to engage with your dedicated BSI Product Expert and provide immediate responses to their questions. This allows predictability in planning for the review, and can improve the efficiency of the review process.
