Regulatory Affairs

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

MDC provides rigorous regulatory affairs advice and assistance for medical device companies throughout the UK, Europe, North America, and beyond

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

• Compliance with the European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (MDR 2017/746).
• Undertaking all aspects of CE marking, and UKCA marking projects, including classification, clinical evaluation or performance evaluation, validation, technical documentation, and post market activities.
• Undertaking US FDA 510(k)s, PMAs (Premarket Approvals), IDEs (Investigational Device Exemptions), Quality System (QS) Regulations, MDSAP compliance work, mock inspections, and technical documentation.
• Solving regulatory questions on classification, technical files, device master records (DMRs), device history records (DHRs), design history files (DHFs), process validation, software validation and other documentation to satisfy reviewers.
• Providing guidance, assisting in implementation and documentation of medical devices utilizing animal tissues, blood products and medicines.
• 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, including national regulatory bodies, certification 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 China, India, Turkey, Egypt, and Canada.
• Recommending or signposting you to other professionals you need.

If you would 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 Trevor Lewis now.