Regulatory affairs, without the mystique.
Brightbark Cranberry can be your partner for success in the complex and dynamic global regulatory environment.
Do I need a Notified Body for my medical device?
In the EU, all medical devices except Class I require a Notified Body certificate to allow CE marking. The level of assessment varies with the risk of the device. Get in touch to discuss classification.
Who can write a medical device technical file?
A medical device technical file is the cumulative effort of all disciplines, typically drawn together by a regulatory affairs specialist. Whilst individual subject matter experts are best placed to summarise their technical reports, a regulatory specialist can tell the story to the regulator, framing information clearly in relation to the legislative requirements.
Do I need MDSAP certification?
A Medical Device Single Audit Program (MDSAP) certificate is only mandatory for marketing in Canada. In the USA, Australia, Japan and Brazil, the certification is optional, but allows time and cost savings for external audits.
OUR PEOPLE
Joseph Langley MEng CEng MTOPRA
Design - Manufacturing - Quality - Regulatory - Management
Underpinned by 7 years at a leading notified body.
“Success in your regulatory submissions is built on skills and experience - and we can be your partner to provide them.”
- Joseph Langley
REGULATORY AFFAIRS CONSULTING
CONTRACT RESOURCE
REGULATORY AFFAIRS WITH NOTIFIED BODY KNOWLEDGE
Hourly, daily, or monthly - book the additional regulatory resource that you need.
Our specialty is EU and UK schemes, but many of the same standards and approaches apply internationally.
Our device experience is a wide range of orthopaedic and dental implantable and surgical devices, from which the principles can be applied to a range of general (invasive or non-invasive) devices.
