Useful References





• Code of Federal Regulations

• Medical Device Advice

• Medical Device import/ export issues

• Medical Device registration and listing

• Small business guide

• FDA forms

• International Electrotechnical Commision (IEC)

• Canadian Standards Organization (CSA)



Medical Device Quality Systems

• 21 CFR Part 820: Quality System Regulation
• ISO 9000
• ISO 9001
• ISO 13485
• ISO/TR 14969; Medical Devices-Quality Management Systems-Guidance on the Application of ISO13485:2003
• ISO 13488; Quality Systems-Medical Devices-Particular Requirements for the Application of ISO9002; 1996

Medical Device Software

• 21CFR Part 11: Electronic Records; Electronic Signatures
• Guidance for the Content of Premarket Submissions For Software Contained in Medical Devices; 5/98, 5/05
• General Principles of Software Validation: Final Guidance for Industry and FDA Staff; 2002
• Guidance for OTS Software Use in Medical Devices; (draft document);6/97
• Guidance for Industry, FDA Reviewers and Compliance on OTS Software Used in Medical Devices; 9/9/99
• Guidance for Industry Part 11, Electronic Records, Electronic Signatures-Scope and Application; 8/03
• Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review; 1991
• ANSI/AAMI/IEC 62304:2006(revision of ANSI/AAMI SW68:2001); Medical Device Software-Software Life Cycle Processes; 7/06
• Guidance for Industry-Cybersecurity for Networked Medical Devices Containing OTS Software; 1/05
• AAMI TIR32:2004; Medical Device Software Risk Management; 12/04

Human Factors for Medical Devices 
• FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices; Feb 2016
• Do It By Design-An Introduction to HF in medical devices; D. Sawyer; FDA
• ANSI/AAMI HE74:2001; Human Factors Design Process for Medical Devices
• IEC 60601-1-6 (2006); Collateral Standard: Usability
• IEC 60601-1-8; Collateral Standard: Alarm Systems
• IEC 62366: Application of Usability Engineering to Medical Devices; 2015
• Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA; April 2001
• Write it Right; HHS Publication FDA 93-4258, August 1993
• ISO 3864-2 (2004); Design Principles for Product Safety Labels
• ISO 13407-1999: Human Centered Design Processes for Interactive Systems
• Human Factors Principles for Medical Device Labeling; FDA Contract 223-89-6022, Pacific Science and Engineering

Medical Device Validation
Guideline on General Principles of Process Validation

Medical Device Audits
Guide to Inspections of Quality Systems (QSIT GUIDE)

Medical Device Risk
• ISO 14971
• IEC 60601-1-4 Safety Requirements for Programmable Electronic Medical Systems
• IEC 60812: Analysis Techniques for System Reliability-Procedures for FMEA;2006
• IEC 61025; Fault Tree Analysis (FTA);2006
• Implementation of Risk Management Principles and Activities within a Quality Management System; GHTF Study Group 3; 5/05
• MIL-STD-1629A; 11/80


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