--- title: "Management Review, Definition | MedTech Terms" description: "Top-management evaluation of QMS performance at planned intervals. Plain-English Quality & Risk definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/management-review#term", "name": "Management Review", "description": "ISO 13485 clause 5.6 and 21 CFR 820.20 require top management to review the QMS at defined intervals, evaluating audit results, customer feedback, process performance, CAPA, and the need for resources or improvement.", "url": "https://medtechterms.com/terms/management-review", "termCode": "management-review", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/management-review#article", "headline": "Management Review", "description": "Top-management evaluation of QMS performance at planned intervals.", "url": "https://medtechterms.com/terms/management-review", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/management-review" }, "about": { "@id": "https://medtechterms.com/terms/management-review#term" }, "articleSection": "Quality & Risk", "inLanguage": "en", "keywords": "Management Review, Quality & Risk, 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": "ISO 13485:2016", "url": "https://www.iso.org/standard/59752.html", "publisher": { "@type": "Organization", "name": "ISO" } }, { "@type": "CreativeWork", "name": "AAMI - Quality Systems Resources", "url": "https://www.aami.org/standards", "publisher": { "@type": "Organization", "name": "AAMI" } }, { "@type": "CreativeWork", "name": "MDIC Case for Quality", "url": "https://mdic.org/program/case-for-quality/", "publisher": { "@type": "Organization", "name": "MDIC" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-13485#term", "name": "ISO 13485", "url": "https://medtechterms.com/terms/iso-13485" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/qsr#term", "name": "Quality System Regulation", "alternateName": "QSR / 21 CFR 820", "url": "https://medtechterms.com/terms/qsr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/qmsr#term", "name": "Quality Management System Regulation", "alternateName": "QMSR", "url": "https://medtechterms.com/terms/qmsr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/internal-audit#term", "name": "Internal Audit", "url": "https://medtechterms.com/terms/internal-audit" } ] }, { "@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": "Quality & Risk", "item": "https://medtechterms.com/terms?cat=Quality%20%26%20Risk" }, { "@type": "ListItem", "position": 4, "name": "Management Review", "item": "https://medtechterms.com/terms/management-review" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/management-review#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of a management review?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to ensure the ongoing suitability, adequacy, and effectiveness of the Quality Management System, identifying opportunities for improvement and necessary changes." } }, { "@type": "Question", "name": "Who should participate in a management review?", "acceptedAnswer": { "@type": "Answer", "text": "Top management, defined as the person or group of people who directs and controls an organization at the highest level, must participate to ensure decisions are made and resources are allocated effectively." } }, { "@type": "Question", "name": "How often should management reviews be conducted?", "acceptedAnswer": { "@type": "Answer", "text": "ISO 13485:2016 clause 5.6.1 requires management reviews to be planned and carried out at defined intervals. The frequency should be appropriate to the organization's size, nature, and complexity, typically annually but often more frequently for new or rapidly changing organizations." } }, { "@type": "Question", "name": "What are the required inputs for a management review?", "acceptedAnswer": { "@type": "Answer", "text": "Inputs typically include results of audits, customer feedback, process performance and product conformity, status of corrective and preventive actions, follow-up actions from previous management reviews, changes that could affect the QMS, and recommendations for improvement, as per ISO 13485:2016 clause 5.6.2." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Management Review [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)[Startup Lifecycle](/ecosystems/startup-lifecycle) # Management Review Top-management evaluation of QMS performance at planned intervals. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition [ISO 13485](/terms/iso-13485) clause 5.6 and 21 CFR 820.20 require top management to review the QMS at defined intervals, evaluating audit results, customer feedback, process performance, [CAPA](/terms/capa), and the need for resources or improvement. What the regulation says Management review is a mandatory activity for medical device manufacturers, as stipulated by regulations like 21 CFR 820.20(c) from the FDA and standards such as [ISO 13485](/terms/iso-13485):2016 clause 5.6. These reviews ensure the continuing suitability, adequacy, and effectiveness of the Quality Management System (QMS). The reviews must include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives. ## What this means in practice Management reviews should produce documented decisions and actions. Inspectors often request meeting minutes and follow-up evidence. ## Examples - A MedTech company reviews its QMS annually, where top management examines internal audit reports, customer complaint trends, and production output data to decide on resource allocation for new equipment. - During a management review, a manufacturer identifies a recurring issue with product non-conformities and decides to initiate a corrective action plan, including retraining production staff. - Following new regulatory updates, a management review meeting assesses the impact on the QMS and approves changes to design control procedures to maintain compliance with EU MDR Annex I. Common pitfalls - • Failing to document management review outputs, including decisions and actions, can lead to audit findings. - • Not involving appropriate top management personnel in the review process undermines its effectiveness and regulatory compliance. - • Conducting reviews as a mere formality, without genuine critical evaluation and follow-up on identified actions, is a common pitfall. - • Excluding crucial inputs, such as audit results, customer feedback, or process performance data, can result in an incomplete and ineffective review. - • Delaying or omitting corrective and preventive actions (CAPA) identified during management review can lead to systemic quality issues and regulatory non-compliance. ## Frequently asked questions What is the primary purpose of a management review? The primary purpose is to ensure the ongoing suitability, adequacy, and effectiveness of the Quality Management System, identifying opportunities for improvement and necessary changes. Who should participate in a management review? How often should management reviews be conducted? What are the required inputs for a management review? ## Cross-references ### Follows Comes after in a typical workflow or lifecycle. - [ Internal Audit ](/terms/internal-audit) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Internal Audit Planned, independent evaluation of QMS conformity and effectiveness. ](/terms/internal-audit)[ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality & Risk Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr)[ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 1 AAMI· 1 MDIC· 1 1. [1 ISO 13485:2016 Verified ISO · iso.org ](https://www.iso.org/standard/59752.html) 2. [2 AAMI - Quality Systems Resources Verified AAMI · aami.org ](https://www.aami.org/standards) 3. [3 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [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 Quality & Risk Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=management-review) Learn in 60 seconds Card Lesson Quiz Top-management evaluation of QMS performance at planned intervals. - · Management reviews should produce documented decisions and actions. - · Inspectors often request meeting minutes and follow-up evidence. Remember this Watch out: Failing to document management review outputs, including decisions and actions, can lead to audit findings. Related terms - [ISO 13485 ](/terms/iso-13485) - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Internal Audit ](/terms/internal-audit) You may also need Auto-suggested from Quality & Risk and shared keywords. - [CAPA Effectiveness Check ](/terms/capa-effectiveness) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Change Control ](/terms/change-control) - [Document Control ](/terms/document-control) - [IQ / OQ / PQ ](/terms/iq-oq-pq) - [Management Representative ](/terms/management-representative) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.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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