iv
Figures
Figure 2-1. Regulatory Fragmentation of Software as a Medical Device. ..................................................................5
Figure 2-2. App to Detect Fever. ...............................................................................................................................7
Figure 2-3. A PACS System With Two Plugins. .....................................................................................................12
Figure 2-4. Scenario 1: Wearable and Software are an Integral Part of a Medical Device. ......................................13
Figure 2-5. Scenario 2: Wearable is an Accessory for SaMD/MDSW. ...................................................................14
Figure 2-6. Scenario 3: Software as an Accessory for Medical Device Wearable. ....................................................15
Figure 2-7. Scenario 4: Only Software is a Medical Device, Wearable Not Subject to Regulation..........................16
Figure 2-8. Scenario 5: Wearable and Software are Placed on the Market as a System. ..........................................17
Figure 3-1. Decision Steps to Assist Qualification as an IVD or MD MDSW for the EU. ...................................23
Figure 3-2. Example of FDA IVD Generic Device Type Regulation. .....................................................................30
Figure 3-3. Example of FDA Product Classification Database Search and Results. ................................................32
Figure 4-1. Overview of EU IVDR Classification Rules. ........................................................................................45
Figure 4-2. Overview of EU MDR Classification Rules..........................................................................................46
Figure 4-3. Insulin Dose Calculator App That Drives an Insulin Pump. .................................................................47
Figure 4-4. An X-ray System Comprised of Dependent and Independent Software...............................................48
Figure 4-5. Digital Thermometer With a Fever Alert Function...............................................................................49
Figure 4-6. An Accessibility App for Patients With Locked-In Syndrome.............................................................50
Figure 4-7. Illustration of How EU MDR Rule 11a Maps on the IMDRF SaMD Risk Framework.....................52
Figure 4-8. Examples of SaMD Mapped Against IMDRF Risk Framework..........................................................53
Figure 4-9. Industry Interpretation of SaMD Risk Framework...............................................................................54
Figure 4-10. Conformity Assessment Procedures Under EU MDR Article 52.......................................................57
Figure 4-11. Illustration of Extent of Notified Body Review for Increasing Device Classification..........................58
Figure 4-12. Path to Market in the US According to Device Class. ........................................................................59
Figure 5-1. Clinical Evaluation Process....................................................................................................................64
Figure 5-2. Clinical Evidence Components for SaMD............................................................................................66
Figure 6-1. Sequence of Events for an IVD Device. ................................................................................................81
Figure 7-1. SaMD Security......................................................................................................................................94
Figure 7-2. Security Monitoring Flowchart. ............................................................................................................99
Figure 8-1. Software Development According to the ‘Waterfall’ Approach...........................................................107
Figure 8-2. Software System Decomposition Into Software Items. .......................................................................112
Figure 8-3. IEC 62304 Development Processes for Incremental Execution. .........................................................114
Figure 8-4. Mapping IEC 62304 Software Development Process Steps to Agile Incre........................................115
Figure 8-5. IEC 62304 and IEC 62366-1 Development Processes for Incremental Execution.............................116
Figure 9-1. Device Use Concept. ...........................................................................................................................127
Figure 10-1. Design for Happiness. .......................................................................................................................133
Figure 10-2. Relationship Between User Needs, Requirements, and Design Specifications..................................135
Figure 10-3. Examples of Usability Roles and Responsibilities..............................................................................136
Figures
Figure 2-1. Regulatory Fragmentation of Software as a Medical Device. ..................................................................5
Figure 2-2. App to Detect Fever. ...............................................................................................................................7
Figure 2-3. A PACS System With Two Plugins. .....................................................................................................12
Figure 2-4. Scenario 1: Wearable and Software are an Integral Part of a Medical Device. ......................................13
Figure 2-5. Scenario 2: Wearable is an Accessory for SaMD/MDSW. ...................................................................14
Figure 2-6. Scenario 3: Software as an Accessory for Medical Device Wearable. ....................................................15
Figure 2-7. Scenario 4: Only Software is a Medical Device, Wearable Not Subject to Regulation..........................16
Figure 2-8. Scenario 5: Wearable and Software are Placed on the Market as a System. ..........................................17
Figure 3-1. Decision Steps to Assist Qualification as an IVD or MD MDSW for the EU. ...................................23
Figure 3-2. Example of FDA IVD Generic Device Type Regulation. .....................................................................30
Figure 3-3. Example of FDA Product Classification Database Search and Results. ................................................32
Figure 4-1. Overview of EU IVDR Classification Rules. ........................................................................................45
Figure 4-2. Overview of EU MDR Classification Rules..........................................................................................46
Figure 4-3. Insulin Dose Calculator App That Drives an Insulin Pump. .................................................................47
Figure 4-4. An X-ray System Comprised of Dependent and Independent Software...............................................48
Figure 4-5. Digital Thermometer With a Fever Alert Function...............................................................................49
Figure 4-6. An Accessibility App for Patients With Locked-In Syndrome.............................................................50
Figure 4-7. Illustration of How EU MDR Rule 11a Maps on the IMDRF SaMD Risk Framework.....................52
Figure 4-8. Examples of SaMD Mapped Against IMDRF Risk Framework..........................................................53
Figure 4-9. Industry Interpretation of SaMD Risk Framework...............................................................................54
Figure 4-10. Conformity Assessment Procedures Under EU MDR Article 52.......................................................57
Figure 4-11. Illustration of Extent of Notified Body Review for Increasing Device Classification..........................58
Figure 4-12. Path to Market in the US According to Device Class. ........................................................................59
Figure 5-1. Clinical Evaluation Process....................................................................................................................64
Figure 5-2. Clinical Evidence Components for SaMD............................................................................................66
Figure 6-1. Sequence of Events for an IVD Device. ................................................................................................81
Figure 7-1. SaMD Security......................................................................................................................................94
Figure 7-2. Security Monitoring Flowchart. ............................................................................................................99
Figure 8-1. Software Development According to the ‘Waterfall’ Approach...........................................................107
Figure 8-2. Software System Decomposition Into Software Items. .......................................................................112
Figure 8-3. IEC 62304 Development Processes for Incremental Execution. .........................................................114
Figure 8-4. Mapping IEC 62304 Software Development Process Steps to Agile Incre........................................115
Figure 8-5. IEC 62304 and IEC 62366-1 Development Processes for Incremental Execution.............................116
Figure 9-1. Device Use Concept. ...........................................................................................................................127
Figure 10-1. Design for Happiness. .......................................................................................................................133
Figure 10-2. Relationship Between User Needs, Requirements, and Design Specifications..................................135
Figure 10-3. Examples of Usability Roles and Responsibilities..............................................................................136