Active Implantable Medical Devices

Active Implantable Medical Devices

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Active Implantable Medical Devices
Active Implantable Medical Devices
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Placing your AIMD product on the market

As an AIMD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to 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 new UKCA Scheme.

We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.




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