General Medical Devices

General Medical Devices

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General Medical Devices
General Medical Devices
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Placing your general medical device on the market

As a manufacturer of general medical devices, you must ensure that your product meets the relevant regulatory requirements before being placed on the market.

It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

Notified Body - BSI The Netherlands (2797) - reviews medical devices to ensure their conformity to the European Directives and Regulations.

Approved Body - BSI UK (0086) - provides conformity assessments under the UKCA Scheme.

We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer standard and dedicated review services providing you with efficient pathways to bring your device to market.

 

Neill Bannister

Meet our experts

Our highly trained technical specialists have an average of 20 years’ industry and regulatory experience, including product design and development, manufacturing and testing. They will support you through the process of certifying your device under the EU MDR and/or UK MDR 2002.

Where products require additional expertise, we collaborate with our in-house clinicians and other technical teams covering all areas from active and active implantable, to medicinal substances, vascular, dental, orthopedic, devices utilizing animal tissue and sterile medical devices.


general medical devices