Clinigen simplifies the path to medical device compliance—from classification to full regulatory submission.

Our experts craft robust technical documentation that meets the demands of regulators, auditors, and Notified Bodies.

Backed by deep cross-functional experience and strategic insight, we deliver clear, confident guidance—including for complex drug-device combinations.

Drug Device Combinations
  • Integrated internal coordination to optimize Drug-Device Combination (DDC) compliance outcomes
  • Support in meeting general safety and performance requirements for your DDC
  • Guidance through CE Marking, Notified Body Opinion (NBOp), and Marketing Authorisation pathways
  • Proven track record: over 100 global Marketing Authorisations prepared and approved
  • Global dossier submissions to EMA, FDA, Health Canada, TGA, and national European agencies
  • End-to-end support across pre-application, submission prep, review, and agency interactions
CE Marking
  • Creation of tailored regulatory roadmaps
  • Preparation of technical documentation, including:
  • Gap analysis of existing documentation
  • Technical writing to address identified gaps
  • Pre-submission review of technical files
  • Corrective action guidance for Notified Body feedback
UKCA Marking
  • Regulatory Roadmaps
  • Technical documentation preparation, including Clinical Evaluation Reports and Risk Management Reports to meet required standards and guidance
  • Gap analysis of existing regulatory technical documentation
  • Technical writing to fill any gaps in documentation, including from EU to UK requirements
  • Pre-submission review of UKCA Technical Documentation
  • Corrective action advice for any issues highlighted by a UK Approved Body
  • UKRP Services
UK Responsible Person
  • Access to individuals with expert knowledge in regulatory compliance
  • Registration using Clinigen as your responsible person
  • Vigilance tracking and reporting including communication with relevant interested parties
  • Maintaining document files for questions arising from the MHRA
  • General regulatory correspondence in the UK as required
Internal and supplier audits
  • Develop an Audit Programme from review of previous audit results, areas of risk and to reflect your wider management system
  • Carry out Internal and Supplier Audits with all audit preparation, planning & reporting
  • Verification of audit nonconformities, including analysis of data and trending
  • Provide feedback into the management review meeting via an audit report
  • Audits carried out by IRCA trained and registered Auditors