--- title: "RAPS Definition & Meaning | MedTech Terms" description: "Global professional society for regulatory affairs across health-product industries. Plain-English Industry Bodies definition for MedTech teams, with examples a" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/raps#term", "name": "Regulatory Affairs Professionals Society", "alternateName": "RAPS", "description": "RAPS is the largest global organization for regulatory affairs professionals across pharmaceuticals, medical devices, IVDs, biologics, and digital health. 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It is widely respected across the medical device, pharmaceutical, and biotechnology industries worldwide." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Industry Bodies](/terms?cat=Industry%20Bodies) 6. / 7. Regulatory Affairs Professionals Society [All terms](/terms) Industry Bodies [Strategic Landscape](/ecosystems/strategic-landscape)RAPS # Regulatory Affairs Professionals Society Global professional society for regulatory affairs across health-product industries. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition RAPS is the largest global organization for regulatory affairs professionals across pharmaceuticals, medical devices, IVDs, biologics, and digital health. Administers the Regulatory Affairs Certification ( [RAC](/terms/rac-audit)) credential. What the regulation says While not a regulatory body itself, the Regulatory Affairs Professionals Society (RAPS) significantly influences regulatory best practices. Regulatory agencies often engage with RAPS through various forums, acknowledging its role in professional development and dissemination of regulatory knowledge, which indirectly supports compliance with regulations like the FDA's 21 CFR Part 820 ( [Quality System Regulation](/terms/qsr)) and the EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745). ## What this means in practice [RAC](/terms/rac-audit) certification is a common professional standard for MedTech regulatory staff. RAPS conferences and publications are widely used for ongoing FDA/EU [MDR](/terms/mdr-reporting)/global regulatory updates. ## Examples - A regulatory affairs specialist preparing for an FDA audit uses RAPS resources to understand the latest interpretations of 21 CFR Part 820. - A startup MedTech company encourages its regulatory team to obtain RAC certification to enhance their understanding of EU MDR requirements. - A quality engineer attends a RAPS conference to learn about emerging cybersecurity regulations impacting medical devices and digital health. Common pitfalls - • Assuming RAPS guidance is mandatory regulation, as RAPS is a professional organization and not a regulatory authority. - • Failing to supplement RAPS resources with direct study of official regulatory texts and guidance documents. - • Believing that RAC certification alone guarantees regulatory compliance without continuous professional development and practical application of knowledge. - • Underestimating the value of networking within RAPS for understanding diverse interpretations and industry trends. ## Frequently asked questions What is the primary mission of RAPS? RAPS is dedicated to supporting regulatory professionals and advancing the regulatory profession, primarily in healthcare product sectors like medical devices, pharmaceuticals, and biotechnology. It provides education, networking opportunities, and professional development resources. How does RAPS support compliance with MedTech regulations? Is RAC certification recognized globally? ## Related terms Grouped by theme ### More in Industry Bodies · Same category [ Industry Bodies AAMI(AAMI) Standards body for medical instrumentation; co-publisher of ISO/IEC adoptions. ](/terms/aami)[ Industry Bodies AdvaMed U.S. trade association for the medical device and diagnostics industry. ](/terms/advamed)[ Industry Bodies AdvaMedDx Diagnostics-focused division of AdvaMed. ](/terms/advameddx)[ Industry Bodies Contract Research Organization(CRO) Service organization providing clinical trial management and supporting services to sponsors. ](/terms/cro) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 RAPS· 1 AAMI· 1 AdvaMed· 1 1. [1 RAPS Verified RAPS · raps.org ](https://www.raps.org/) 2. [2 AAMI Verified AAMI · aami.org ](https://www.aami.org/) 3. [3 AdvaMed Verified AdvaMed · advamed.org ](https://www.advamed.org/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Aligning your program with industry guidance? We help MedTech teams operationalize cybersecurity guidance from IMDRF, HSCC, AAMI, and other industry bodies. [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 Industry Bodies Acronym RAPS Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=raps) Learn in 60 seconds Card Lesson Quiz Global professional society for regulatory affairs across health-product industries. - · RAC certification is a common professional standard for MedTech regulatory staff. - · RAPS conferences and publications are widely used for ongoing FDA/EU MDR/global regulatory updates. - · Administers the Regulatory Affairs Certification (RAC) credential. Remember this Watch out: Assuming RAPS guidance is mandatory regulation, as RAPS is a professional organization and not a regulatory authority. You may also need Auto-suggested from Industry Bodies and shared keywords. - [AdvaMed ](/terms/advamed) - [MedTech Innovator ](/terms/medtech-innovator) - [Health Information Sharing and Analysis Center(H-ISAC) ](/terms/h-isac) - [Contract Research Organization(CRO) ](/terms/cro) - [Texas Medical Center Innovation(TMC Innovation) ](/terms/texas-medical-center) - [Pharmaceuticals and Medical Devices Agency(PMDA) ](/terms/pmda) [All Industry Bodies terms](/terms?cat=Industry%20Bodies) 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. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)