(PhD Biomedical Engineering / ILM Level 7)
PRECISION IN
REGULATORY AFFAIRS.
Independent senior RAQAC consultancy for the medical device industry. Quality Assurance, Regulatory Affairs, Validation, Risk Management, Clinical Research and Regulatory Strategy across EU, UK and US markets.
RCF Consulting — Est. BelfastExperienced RAQAC professional with a demonstrated history in the medical device industry.
Skilled in Quality Assurance, Regulatory Affairs, Validation, Risk Management, Research and Development (R&D), Good Laboratory Practice (GLP), Clinical Research, Medical Devices, Regulatory Strategy & Submissions, and Business Management.
Strong research professional with a Doctor of Philosophy (PhD) focused in Biomedical / Medical Engineering from the University of Ulster, and ILM Level 7 in Leadership and Management.
Three pillars of support
End-to-end consultancy across the medical device lifecycle — from regulatory strategy to post-market clinical follow-up.
Regulatory Support
- 01Evaluate, update or prepare EU MDR technical files for CE marking — including risk classification, GSPR checklist, design, development and manufacturing details
- 02Evaluate, update or prepare UK MDR files for UKCA marking
- 03IEC 62366 Human Factors and Usability Engineering documentation and training
- 04ISO 14971 Risk Management for medical devices — documentation and training
- 05US FDA 510(k), De Novo and pre-market authorisation submission support: device descriptions, risk/benefit, substantial equivalence, executive summaries, clinical summaries, human factors summaries
- 06Regulatory roadmap design across EU MDR, UK MDR and US FDA requirements
- 07Documentation review (Product Requirements, Product Architecture, IFU)
- 08Training for client employees on EU MDR requirements and relevant MDCG guidance
Quality Support
- 01ISO 13485:2016 Quality Management System design and implementation
- 02Audit preparation support
- 03Internal audits
- 04QMS standards training
Clinical Support
- 01Advisory support for clinical evidence-generation strategies
- 02Writing and updating Clinical Evaluation Plans, Clinical Investigation documents, PMCF plans & reports, PMS plans & reports, and Clinical Evaluation Reports — including literature review protocols and reports
- 03Advisory support on real-world evidence and post-market surveillance strategies
- 04Clinical standards training
Core regulatory standards and frameworks covered.
Initiate engagement.
Brief your requirements for a comprehensive assessment of your regulatory position. All engagements begin with a confidential scope alignment.