Downloads
This page contains useful downloads and resources. Please click a link below to download:
- Does Europe Still Need Notified Bodies?
- Regulatory Comparative Analysis: Medical Devices (Amendment) Regulations 2026 vs UK MDR 2002 (as amended by SI 2023/627)
- Significant Change: A Comparative Analysis of Change Management Frameworks for Medical Devices
- MHRA Consultation Decision Matrix
- Risk Management Summary
- Whitepaper - Strategic Regulatory Planning: Navigating Global Compliance
- UK PMS Requirements - Part 4
- UK PMS Requirements - Part 3
- IVDR transition deadlines
- UK PMS Requirements - Part 2
- UK PMS Requirements - Part 1
External links
This area contains links to key regulatory websites that may prove helpful.
- MHRA (UK)
- FDA (United States)
- EU Commission
- Health Canada
- TGA (Australia)
- PMDA (Japan)
- Anvisa (Brazil)