All pathsPMS · QA · RA · 9 terms

Post-Market Mastery

Name: Post-Market Mastery
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Surveillance, vigilance, recalls, and the feedback loop into risk and design.

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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.
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.
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.
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.
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.
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.
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.
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.
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.

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Post-Market Mastery

Post-Market Surveillance(PMS)

Periodic Safety Update Report(PSUR)

Medical Device Vigilance

Field Safety Corrective Action(FSCA)

Medical Device Recall

Medical Device Reporting (FDA)(MDR)

Complaint Handling

Corrective and Preventive Action(CAPA)

Real-World Evidence(RWE)