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
  • 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

Clinigen lifecycle services also provides medical device training, allowing delegates and their companies to benefit from up-to-date information from specialists.

Our trainers are active consultants with hands on experience of medical device requirements for quality and regulatory. They have been involved in the implementation and maintenance of multiple quality management systems and approval of associated devices.

Courses offered by Kinesys include:

Introduction to ISO 13485 -

• Quality management systems
• Overview of ISO 13485:2016
• Documentation requirements of ISO 13485:2016
• Why we need management responsibility
• Provision of resources
• Product manufacture & service delivery
• Improvement & system effectiveness

Risk Management using ISO 14971:2019 -

• Risk management systems
• Benefit-Risk Evaluation
• Risk acceptability criteria and state-of-the-art
• ISO 14971:2019/BS EN ISO 14971:2019 in practice
• Risk assessment tools & techniques
• Failure Mode Effect Analysis in Action (FMEA)
• Risk control strategies and reporting
• The risk management life cycle

Changes implemented by MDR 2017/745 affecting Medical Device Manufacturers -

• Legislative and operational Basis of CE Marking
• New Classification and conformity routes
• New Safety and Performance requirements
• Updated requirements for Technical Documentation (incl. UDI and Clinical Evaluation)
• EUDAMED and Statutory Reporting
• Health care institute in house manufacturing
• Responsible person
• Identification within the supply chain
• Electronically Programmed Systems
• Implant Card

Changes implemented by MDR 2017/746 affecting IVD Manufacturers -

• Quality management systems
• Scope of regulated IVDs
• Key compliance dates
• Classification and conformity
• Assessment requirements
• Person responsible for regulatory compliance
• Identification and traceability
• Performance evaluation requirements
• Vigilance and market surveillance

ISO 13485 Internal Auditors Course -

• An overview of QMS requirements and ISO 13485, including the Plan, Do, Check,
Act Cycle and the Process Approach
• Introduction to the audit life cycle
• Audit planning and preparation considerations
• Techniques to make the most of the audit time allocated, when collecting
evidence, including sampling and adoption of a risk-based approach
• Audit Interview skills to create a robust audit trail
• Evaluation practise, ensuring findings are objective and made against the audit
criteria
• Guidance for writing non-conformity reports that avoid ambiguity and challenges
• Appreciation of the need to follow-up and close out audit findings to improve the QMS

These course are available at your offices/facilities by arrangement.

These courses are taught by Medical Devices expert Dr Edward Staunton, Director of Quality and Regulatory Affairs. He is an IRCA Certified Lead Auditor who has trained numerous internal auditors, notified body audits and lead auditors. To book please email contactcls@clinigengroup.com