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 throughout 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) and In Vitro Diagnostic Regulation (IVDR).
  • Undertaking all aspects of CE 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, mock inspections and technical documentation.
  • Undertaking regulatory compliance work for various other jurisdictions including Canada and Russia for both devices and IVDs.
  • 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, 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 China, India, Turkey, Egypt and Canada.

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.

We provide specialist advice and assistance for medical device companies throughout Europe, North America and beyond…

Should you require any further information simply call us on 01630 67 37 37