Regulatory Affairs

Robust regulatory affairs advice, to help you get to market and stay there

We provide rigorous regulatory affairs advice and assistance for medical device companies in the United Kingdom, throughout Europe, North America and beyond

Services provided are wide ranging and include, but are not limited to:

• United Kingdom regulatory compliance, including strategic advice, training and assistance with implementation.
• European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) strategic advice, training and assistance with implementation.
• United States (US) Food and Drug Administration (FDA) strategic advice, training and assistance with implementation.
• Undertaking regulatory compliance work for various other jurisdictions including Canada and Russia for both medical devices and IVDs.
• Solving regulatory questions on classification, technical files, device master records (DMRs) and related documentation.
• Providing usability and human factors engineering (HFE) insights, advice and contacts.
• Acting as an expert witness and/or specialist advisor to legal counsel and/or top management.
• Training of national regulators, notified bodies and international consultants, especially those who train other trainers.
• Provision of regulatory guidance and advice to national governments and officials in countries such as Canada, China, Egypt, Turkey and India.

If you’d like to know more about how our experience and knowledge in regulatory affairs can enhance and reinforce your medical device proposition, please feel free to contact us here.