Postmarket Requirements for Medical Devices: A Practical Guide
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Figure 2-5. Overview of Recall Process. ...............................................................................................39
Figure 2-6. UDI Example..................................................................................................................... 42
Figure 2-7. Unique Device Identification System: Three Distinct Concepts. .......................................43
Figure 6-1. Significant Changes Under Article 120 of the EU MDR.................................................. 97
Figure 9-1. TGA Process for Notification of a Substantial Change. ..................................................144
Figure 10-1. PMDA Postmarket Safety Measures ..............................................................................157
Figure 10-2. Stages of a Recall............................................................................................................. 161
Figure 18-1. Premarket Highlights from Medical Device Cybersecurity Guidance for Industry......... 322
Abbreviations and Acronyms. ...............................................................................................................335
Glossary of Terms.................................................................................................................................. 339
Index..................................................................................................................................................... 347