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Your progress 0 of 9 lessons complete · up next: Post-Market Surveillance [Start path](/terms/post-market-surveillance?from=post-market-mastery) 1. 1 [ Post-Market ## Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. Why this term here: The umbrella process. Focus on the PMS plan and how it feeds every other artifact on this path. ](/terms/post-market-surveillance?from=post-market-mastery)Mark done 2. 2 [ Post-Market ## Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. Why this term here: The EU periodic report. Focus on class-driven cadence and how PSUR content is assembled from PMS data. ](/terms/psur?from=post-market-mastery)Mark done 3. 3 [ Post-Market ## Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. Why this term here: Serious incident reporting in the EU. Focus on the report timelines and what counts as a serious incident. ](/terms/vigilance?from=post-market-mastery)Mark done 4. 4 [ Post-Market ## Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. Why this term here: Field Safety Corrective Action. Focus on the FSN template and how FSCA connects to vigilance reporting. ](/terms/fsca?from=post-market-mastery)Mark done 5. 5 [ Post-Market ## Medical Device Recall Removal or correction of a marketed device that violates FDA law. Why this term here: The US corrective action. Focus on Class I/II/III and how classification drives customer communication. ](/terms/recall?from=post-market-mastery)Mark done 6. 6 [ Post-Market ## Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. Why this term here: US Medical Device Reporting. Focus on the 30-day and 5-day timelines and who has reporting duties. ](/terms/mdr-reporting?from=post-market-mastery)Mark done 7. 7 [ Quality & Risk ## Complaint Handling Process for receiving, evaluating, and responding to device complaints. Why this term here: The intake process feeding all of the above. Focus on complaint definition and the reportability decision tree. ](/terms/complaint-handling?from=post-market-mastery)Mark done 8. 8 [ Quality & Risk ## Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. Why this term here: The action system for systemic issues. Focus on when a single complaint should trigger a CAPA versus when it should not. ](/terms/capa?from=post-market-mastery)Mark done 9. 9 [ Clinical & Trials ## Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. Why this term here: Post-market data reused for evidence generation. Focus on when RWE can support new indications or label expansions. ](/terms/real-world-evidence?from=post-market-mastery)Mark done Finished the path? Test yourself with a quiz tailored to these 9 terms. [Take the Post-Market Mastery quiz](/quiz?path=post-market-mastery) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. 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