ix
Section V: Inspection, Compliance, and Enforcement
Chapter 23 Compliance and Enforcement. ............................................................................................................377
By David W. Husman, PhD, ASQ CPGP, RAC and John Rossman, MBEE, RAC
Chapter 24 FDA Inspection and Enforcement.......................................................................................................399
By Robert Rogers, MS, RAC
Chapter 25 Components of a REMS: Communication Plans and Implementation Systems.................................411
By Edward Tabor, MD
Chapter 26 Components of a REMS: Elements to Assure Safe Use......................................................................413
By Edward Tabor, MD
Chapter 27 Components of a REMS: REMS Assessment.....................................................................................419
By Edward Tabor, MD
Chapter 28 Risk Management in the Medical Device and Food Industries. ..........................................................423
By Salma Michor, PhD, MBA, CMgr, CQA, RAC
Tables
Table 1-1. Key Differences Between ISO 9001 and ISO 13485. ......................................................................................................1
Table 1-2. Similarities Between ISO 9001 and ISO 13485............................................................................................................... 2
Table 1-3. Comparison of ISO 13485:2003 and ISO 13485:2016.................................................................................................... 6
Table 1-4. Applicability of ISO 13485 in Various Global Jurisdictions........................................................................................... 12
Table 1-5. Benefits and Barriers to Certification............................................................................................................................. 20
Table 1-6. Certification Body QMS Assessment Objectives, Scope and Criteria. ..........................................................................20
Table 1-7. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers. ........................................................22
Table 1-8. Factors That May Increase or Reduce Audit Durations. ................................................................................................22
Table 4-1. PIC/S Member States.................................................................................................................................................... 78
Table 6-1. Traditional Quality Management vs. QRM Approach................................................................................................. 101
Table 9-1. The Universal Elements of GLP................................................................................................................................... 123
Table 9-2. Examples of GLP Violations From FDA Warning Letters. ........................................................................................124
Table 9-3. Sources of Device Risk................................................................................................................................................. 125
Table 9-4. Biocompatibility Tests. .................................................................................................................................................125
Table 9-5. Medical Device Classification Based on the Nature of Body Contact and Contact Duration. ....................................126
Table 9-6. Basic Animal Study Protocol Elements........................................................................................................................ 127
Table 9-7. Animal Models for In Vivo Medical Device Assessment............................................................................................. 129
Table 9-8. International Animal Research Laws, Policies and Guidelines. ...................................................................................129
Table 9-9. Useful Web Resources for Planning and Conducting Animal Studies in Accordance With the Three Rs’ Principles. ......130
Table 9-10. Questions a Company Should Consider When Selecting a CRO. ............................................................................132
Table 16-1. Select Resources on Pictogram Use............................................................................................................................ 222
Table 17-1. Centralised Procedure Requirements Based on Product Type.................................................................................... 239
Table 17-2. Regulatory Authorities by Country............................................................................................................................ 239
Section V: Inspection, Compliance, and Enforcement
Chapter 23 Compliance and Enforcement. ............................................................................................................377
By David W. Husman, PhD, ASQ CPGP, RAC and John Rossman, MBEE, RAC
Chapter 24 FDA Inspection and Enforcement.......................................................................................................399
By Robert Rogers, MS, RAC
Chapter 25 Components of a REMS: Communication Plans and Implementation Systems.................................411
By Edward Tabor, MD
Chapter 26 Components of a REMS: Elements to Assure Safe Use......................................................................413
By Edward Tabor, MD
Chapter 27 Components of a REMS: REMS Assessment.....................................................................................419
By Edward Tabor, MD
Chapter 28 Risk Management in the Medical Device and Food Industries. ..........................................................423
By Salma Michor, PhD, MBA, CMgr, CQA, RAC
Tables
Table 1-1. Key Differences Between ISO 9001 and ISO 13485. ......................................................................................................1
Table 1-2. Similarities Between ISO 9001 and ISO 13485............................................................................................................... 2
Table 1-3. Comparison of ISO 13485:2003 and ISO 13485:2016.................................................................................................... 6
Table 1-4. Applicability of ISO 13485 in Various Global Jurisdictions........................................................................................... 12
Table 1-5. Benefits and Barriers to Certification............................................................................................................................. 20
Table 1-6. Certification Body QMS Assessment Objectives, Scope and Criteria. ..........................................................................20
Table 1-7. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers. ........................................................22
Table 1-8. Factors That May Increase or Reduce Audit Durations. ................................................................................................22
Table 4-1. PIC/S Member States.................................................................................................................................................... 78
Table 6-1. Traditional Quality Management vs. QRM Approach................................................................................................. 101
Table 9-1. The Universal Elements of GLP................................................................................................................................... 123
Table 9-2. Examples of GLP Violations From FDA Warning Letters. ........................................................................................124
Table 9-3. Sources of Device Risk................................................................................................................................................. 125
Table 9-4. Biocompatibility Tests. .................................................................................................................................................125
Table 9-5. Medical Device Classification Based on the Nature of Body Contact and Contact Duration. ....................................126
Table 9-6. Basic Animal Study Protocol Elements........................................................................................................................ 127
Table 9-7. Animal Models for In Vivo Medical Device Assessment............................................................................................. 129
Table 9-8. International Animal Research Laws, Policies and Guidelines. ...................................................................................129
Table 9-9. Useful Web Resources for Planning and Conducting Animal Studies in Accordance With the Three Rs’ Principles. ......130
Table 9-10. Questions a Company Should Consider When Selecting a CRO. ............................................................................132
Table 16-1. Select Resources on Pictogram Use............................................................................................................................ 222
Table 17-1. Centralised Procedure Requirements Based on Product Type.................................................................................... 239
Table 17-2. Regulatory Authorities by Country............................................................................................................................ 239