As an Orthopaedic and Dental Devices manufacturer, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market
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.
The Orthopaedic and Dental team have a wide range of experience from industry, academia and working the medical device regulatory sector.
This expertise and experience makes BSI the Notified Body and UK Approved Body of choice for the majority of the leading orthopaedic manufacturers.
Orthopaedic and dental devices are generally characterised as devices intended to treat or reconstruct skeletal or dental tissue.
The scope of orthopaedic and dental devices range from the lowest risk and classification (such as reusable instruments) to the highest risks and classification, for example total joint replacements, resorbable devices, orthobiologics, device/drug combination devices.
In addition, total joint replacements of the hip, knee and shoulder are covered under the Commission Supplementary Directive 2005/50/EC.
