Regulatory Advice
Comply with MDR Requirements
As experienced regulatory consultants, we have worked with both large and small companies to help bring Medical Devices products to the UK and EU markets.
What we do
Product Gap Analysis
We assess and then provide a full gap-analysis for new deliverables, ensuring your product data is compliant with UK MDR and EU MDR requirements.
Regulator Communications
Our consultants are experienced liaisons, and they can make communicating with regulating authorities easier for you with an agreed upon level of assistance.
Clinical Investigation Support
We provide comprehensive support with clinical investigation submissions, ensuring they are received by competent and relevant authorities.
Classification Dispute Support
Our team are experienced with classification for medical devices and aid with the classification dispute process to ensure your product is classified correctly.
Other Services
Consult our team
Talk with our regulatory consultants for assistance on complying with medical device regulations.