--- title: "PMS, Post-Market Surveillance | MedTech Terms" description: "Activities to monitor device safety and performance after market release. Plain-English Post-Market definition for MedTech teams, with examples and related term" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/post-market-surveillance#term", "name": "Post-Market Surveillance", "alternateName": "PMS", "description": "Post-Market Surveillance (PMS) comprises the systematic processes a manufacturer establishes to actively collect and review experience gained from devices placed on the market, in order to identify any need to apply corrective or preventive actions.", "url": "https://medtechterms.com/terms/post-market-surveillance", "termCode": "post-market-surveillance", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/post-market-surveillance#article", "headline": "PMS, Post-Market Surveillance", "description": "Activities to monitor device safety and performance after market release.", "url": "https://medtechterms.com/terms/post-market-surveillance", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/post-market-surveillance" }, "about": { "@id": "https://medtechterms.com/terms/post-market-surveillance#term" }, "articleSection": "Post-Market", "inLanguage": "en", "keywords": "Post-Market Surveillance, PMS, Post-Market, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "EU MDR Chapter VII (Post-Market Surveillance)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "MDCG 2022-21 PSUR Template", "url": "https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-21_en.pdf", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "FDA Recalls - Medical Devices", "url": "https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr#term", "name": "EU Medical Device Regulation", "alternateName": "MDR", "url": "https://medtechterms.com/terms/mdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/vigilance#term", "name": "Medical Device Vigilance", "url": "https://medtechterms.com/terms/vigilance" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/capa#term", "name": "Corrective and Preventive Action", "alternateName": "CAPA", "url": "https://medtechterms.com/terms/capa" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/psur#term", "name": "Periodic Safety Update Report", "alternateName": "PSUR", "url": "https://medtechterms.com/terms/psur" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pmcf#term", "name": "Post-Market Clinical Follow-up", "alternateName": "PMCF", "url": "https://medtechterms.com/terms/pmcf" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/risk-management-file#term", "name": "Risk Management File", "alternateName": "RMF", "url": "https://medtechterms.com/terms/risk-management-file" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/fsca#term", "name": "Field Safety Corrective Action", "alternateName": "FSCA", "url": "https://medtechterms.com/terms/fsca" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Post-Market", "item": "https://medtechterms.com/terms?cat=Post-Market" }, { "@type": "ListItem", "position": 4, "name": "Post-Market Surveillance", "item": "https://medtechterms.com/terms/post-market-surveillance" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/post-market-surveillance#faq", "mainEntity": [ { "@type": "Question", "name": "What is the difference between PMS and vigilance?", "acceptedAnswer": { "@type": "Answer", "text": "PMS is the systematic, proactive process of collecting and analyzing all post-market data. Vigilance is the specific reactive process for reporting serious incidents and field safety corrective actions (FSCA) to competent authorities. Vigilance is one input to PMS." } }, { "@type": "Question", "name": "What documents does PMS produce under EU MDR?", "acceptedAnswer": { "@type": "Answer", "text": "For Class I devices: a PMS report (Article 85), updated when necessary. For Class IIa, IIb, and III: a PSUR (Article 86), updated at defined intervals (at least every 2 years for IIa, annually for IIb and III). Both draw on the PMS plan required by Article 84." } }, { "@type": "Question", "name": "Is PMS required in the US?", "acceptedAnswer": { "@type": "Answer", "text": "There is no single 'PMS regulation' but the equivalent obligations exist through complaint handling (21 CFR 820.198), CAPA (820.100), MDR reporting (Part 803), and 522 post-market surveillance orders. QMSR aligns further with ISO 13485 clause 8." } }, { "@type": "Question", "name": "How does PMS interact with PMCF?", "acceptedAnswer": { "@type": "Answer", "text": "Post-Market Clinical Follow-up (PMCF) is the clinical data collection component of PMS under MDR Annex XIV Part B. PMCF confirms safety and performance in the intended use, identifies previously unknown side effects, and supports benefit-risk over the device lifetime. Its outputs feed the PMS report or PSUR." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Post-Market Surveillance [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Startup Lifecycle](/ecosystems/startup-lifecycle)PMS # Post-Market Surveillance Activities to monitor device safety and performance after market release. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Post-Market Surveillance (PMS) comprises the systematic processes a manufacturer establishes to actively collect and review experience gained from devices placed on the market, in order to identify any need to apply corrective or preventive actions. ## What this means in practice PMS is required under EU [MDR](/terms/mdr-reporting) Articles 83-86 and [IVDR](/terms/ivdr) Articles 78-81, and is embedded in FDA's [Quality System Regulation](/terms/qsr) (soon [QMSR](/terms/qmsr)) through [complaint handling](/terms/complaint-handling) (820.198), [CAPA](/terms/capa) (820.100), and MDR reporting (Part 803). Under EU MDR, manufacturers must maintain a PMS plan proportionate to device risk (Article 84), covering active and reactive data collection: vigilance and serious incidents, trend reports (Article 88), user feedback, scientific literature, similar-device data, [PMCF](/terms/pmcf) for Class IIa and above, and PMS reports (Class I) or PSURs (Class IIa+). Outputs feed the [risk management file](/terms/risk-management-file), technical documentation, clinical evaluation, and, where needed, corrective actions and field safety corrective actions ( [FSCA](/terms/fsca)). ## Examples - A Class IIb implantable device team runs quarterly PMS reviews aggregating complaints, PMCF data, and literature searches, updating the RMF and PSUR annually. - A Class IIa SaMD manufacturer maintains an automated pipeline that ingests support tickets, app store reviews, and adverse-event reports into a single PMS dashboard reviewed monthly. ## Use cases 1 scenario 1 ### PMS plan for a connected insulin pen cap Post-market team The PMS plan defines complaint trending, app analytics review, literature monitoring, and a registry partnership. Inputs feed a [PSUR](/terms/psur) every two years and a continuously updated risk file. Outcome An emerging usability issue is detected within one quarter and fixed via a [labeling](/terms/labeling) change before it becomes a vigilance event. Common pitfalls - • Confusing PMS (proactive, plan-driven) with vigilance (reactive, incident-driven). MDR Article 83 explicitly distinguishes them; you need both. - • Under-scoping PMS to complaints only. MDR expects trend analysis, literature review, similar-device data, and PMCF results as well. - • Missing the trend reporting obligation. MDR Article 88 requires reporting statistically significant increases in non-serious incidents or expected side effects. - • Treating PMS as separate from the RMF. PMS outputs must be linked to risk analysis updates and, where relevant, to CAPA. ## Frequently asked questions What is the difference between PMS and vigilance? PMS is the systematic, proactive process of collecting and analyzing all post-market data. Vigilance is the specific reactive process for reporting serious incidents and field safety corrective actions ( [FSCA](/terms/fsca)) to competent authorities. Vigilance is one input to PMS. What documents does PMS produce under EU MDR? Is PMS required in the US? How does PMS interact with PMCF? ## Cross-references ### Follows Comes after in a typical workflow or lifecycle. - [ 510(k) Premarket Notification(510(k)) ](/terms/510k) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa) ### Post-Market Mastery · From this learning path [ Post-Market Medical Device Recall Removal or correction of a marketed device that violates FDA law. ](/terms/recall?from=post-market-mastery)[ Post-Market Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. ](/terms/mdr-reporting?from=post-market-mastery)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=post-market-mastery)[ Clinical & Trials Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. ](/terms/real-world-evidence?from=post-market-mastery) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Post-Market Mastery](/paths/post-market-mastery)Lesson 1 of 9 Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Mentioned in recent activity 12 entries Recalls (10)PubMed (2) [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1719-2026) Class I · 2026-02-27 [NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1713-2026) Class I · 2026-02-27 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1716-2026) Class I · 2026-02-27 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1714-2026) Class I · 2026-02-27 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1720-2026) Class I · 2026-02-27 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1728-2026) Class I · 2026-02-27 [NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1712-2026) Class I · 2026-02-27 [NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1718-2026) Class I · 2026-02-27 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1723-2026) Class I · 2026-02-27 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medline SKU # DYNJ82411. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1722-2026) Class I · 2026-02-27 ## Latest in MedTech [View all](/latest?term=post-market-surveillance) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-05-01 [Post-market surveillance for literature on QuantiFERON TB Gold Plus: what improvements can artificial intelligence bring? ](https://pubmed.ncbi.nlm.nih.gov/42125013/) IJTLD open - Recall 2026-02-27 [NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1713-2026) Class I · Medline Industries, LP - Recall 2026-02-27 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1716-2026) Class I · Medline Industries, LP ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 European Commission· 1 FDA· 1 1. [1 EU MDR Chapter VII (Post-Market Surveillance) Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745) 2. [2 MDCG 2022-21 PSUR Template Unchecked European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-21_en.pdf) 3. [3 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Acronym PMS Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=post-market-surveillance) Learn in 60 seconds Card Lesson Quiz Activities to monitor device safety and performance after market release. - · Outputs feed the risk management file, technical documentation, clinical evaluation, and, where needed, corrective actions and field safety corrective actions (FSCA). Remember this Watch out: Confusing PMS (proactive, plan-driven) with vigilance (reactive, incident-driven). MDR Article 83 explicitly distinguishes them; you need both. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [Medical Device Vigilance ](/terms/vigilance) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Periodic Safety Update Report(PSUR) ](/terms/psur) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Risk Management File(RMF) ](/terms/risk-management-file) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) You may also need Auto-suggested from Post-Market and shared keywords. - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Customer Notification Letter ](/terms/customer-notification) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Surveillance Plan ](/terms/pms-plan) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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