Regulatory Knowledge Library
Access templates, checklists, and guides to accelerate your compliance documentation.
ISO 13485 QMS Template
A starter template for building your Quality Management System.
Risk Management Plan (ISO 14971)
Template for documenting risk analysis and mitigation.
EU MDR Gap Analysis Checklist
A checklist to assess your readiness for the Medical Device Regulation.
FDA 510(k) Submission Checklist
Ensure all required sections are included in your 510(k) submission.
Clinical Evaluation Report (CER) Template
A structured template for writing your CER under EU MDR.
Cybersecurity Threat Model for SaMD
A guide to identifying and mitigating cybersecurity risks.