Recommended references

The following are fundamental documents needed to implement a Quality Management System, establish a Regulatory Affairs framework and develop medical devices.

Standards for medical devices

  1. AAMI TIR36:2007 - Validation of software (tools) for regulated processes
  2. ANSI AAMI ISO EC57:1998-(R)2008 - Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
  3. ANSI AAMI SW87:2012 - Application of quality management system concepts
  4. IEC 62304:2006 - Medical device software - Software life cycle processes
  5. ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
  6. ISO 14155:2011 - Clinical investigation of medical devices for human subjects - Good clinical practice
  7. ISO 14971:2007-R2010 - Medical devices - Application of risk management to medical devices
  8. ISO 15223-1:2010 - Medical devices - Symbols to be used with medical device labeling - Part 1
  9. ISO 15223-2:2010 - Medical devices - Symbols to be used with medical device labeling - Part 2
  10. ISO TR 14969:2004 - Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

Health Canada regulations

  1. SOR-98-282 - Medical devices regulations
  2. Health Canada - List of Recognized Standards for Medical Devices
  3. Health Canada - Software Regulated as a Medical Device - Frequently Asked Questions
  4. Health Canada Guidance - GD207 - Guidance on the Content of ISO 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrars
  5. Health Canada Guidance - GD210 - ISO 13485-2003 Quality Management System Audits Performed by Health Canada Recognized Registrars
  6. Health Canada Guidance - GD211 - Guidance on the Content of Quality Management System audit reports
  7. Health Canada Guidance - Guidance Document for Mandatory Problem Reporting for Medical Devices
  8. Health Canada Guidance - How to Complete the Application for a New Medical Device License
  9. Health Canada Guidance - Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices
  10. Health Canada Guidance - Recognition and Use of Standards under the Medical Devices Regulations
  11. Health Canada Policy - Canadian Medical Devices Conformity Assessment System (CMDCAS)

FDA regulations

  1. 21 CFR Part 11 Electronic Records; Electronic Signatures
  2. 21 CFR Part 803 Medical Device Reporting
  3. 21 CFR Parts 808, 812, and 820 - Medical Devices - Current Good Manufacturing Practices
  4. FDA - 510(k) "Substantial Equivalence" Decision-making Process
  5. FDA - Design Control Guidance for Medical Device Manufacturers
  6. FDA - Do It By Design - An Introduction to Human Factors in Medical Devices
  7. FDA - General Human Factors Information and Resources
  8. FDA - Guide to Inspections of Quality Systems
  9. FDA - Human Factors in the GMP Inspection Process
  10. FDA - Medical Device Reporting for Manufacturers
  11. FDA - Medical Device Reporting for User Facilities
  12. FDA - Premarket Notification (510k)
  13. FDA Guidance (Draft) - Applying Human Factors and Usability Engineering to Optimize Medical Device Design
  14. FDA Guidance - Computerized Systems Used in Clinical Investigations
  15. FDA Guidance - Content of Premarket Submissions for SW Contained in Medical Devices
  16. FDA Guidance - Cybersecurity for Networked Medical Devices Containing OTS SW
  17. FDA Guidance - De Novo Classification Process
  18. FDA Guidance - Deciding When to Submit a 510(k) for a Change to an Existing Device
  19. FDA Guidance - Design Control
  20. FDA Guidance - Factors to Consider When Making Benefit-Risk Determinations
  21. FDA Guidance - FAQs on the New 510(K) Paradigm
  22. FDA Guidance - General & Specific Intended Use
  23. FDA Guidance - General Principles of Software Validation
  24. FDA Guidance - Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors - FAQs about Medical Devices
  25. FDA Guidance - Labeling, Regulatory Requirements for Medical Devices
  26. FDA Guidance - Medical Device Use-Safety - Incorporating Human Factors Engineering into Risk Management
  27. FDA Guidance - Off-The-Shelf Software Use in Medical Devices
  28. FDA Guidance - Part 11, Electronic Records; Electronic Signatures
  29. FDA Guidance - Quality System Information for Certain Premarket Application Reviews
  30. FDA Guidance - The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
  31. FDA Guidance - Use of Standards in Substantial Equivalence Determinations
  32. FDA - Human Factors - Premarket Information - Device Design and Documentation Processes

Global Harmonization Task Force regulations

  1. GHTF/SG1/N43:2005 Labelling for Medical Devices
  2. GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices