The authoritative reference for MedTech terminology.
Clear, sourced definitions for every regulatory, quality, cybersecurity, and software term that shapes modern medical devices. Each term has its own page, with citations and links to primary sources.
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Curated reading orders for FDA cyber, 510(k), QMS, SaMD/AI, EU MDR, and post-market.
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Premarket Approval(PMA)
FDA's most stringent device marketing application, required for high-risk Class III devices.
De Novo Classification Request(De Novo)
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
Quality System Regulation(QSR / 21 CFR 820)
FDA's current good manufacturing practice (cGMP) requirements for medical devices.
Quality Management System Regulation(QMSR)
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
ISO 13485
International standard for medical device quality management systems.
Latest in MedTech
Fresh FDA 510(k) clearances, PMA approvals, recalls, clinical trials, and PubMed publications, auto-linked to glossary terms.
More from the Blue Goat network
Sister sites and references that go deeper on specific topics covered in this glossary.
MedTech Cybersecurity Standards
Authoritative reference for the standards and guidances behind medical device cybersecurity.
MedTech Cyber Tips
Practical, organized tips for medical device cybersecurity teams.
MedTech Cybersecurity Crosswalk
International crosswalk of medical device cybersecurity requirements across regulators.
AI SaMD Insights
How AI is changing SaMD - risk, regulation, and good machine-learning practice.
Code Blue
Real medical device cybersecurity incidents and their lessons.
MedTech Truths
Common misconceptions about medical device development - debunked.
Medical device cybersecurity - premarket submissions, SBOMs, threat modeling, and penetration testing.