Regulatory

Track medical device policy in 2026, from MDUFA V and VALID Act debates to EU MDR implementation, AI regulation, and global trends affecting market access.

Guide to point-of-care testing regulation, including CLIA waivers, FDA pathways, EU IVDR classification, quality management, and near-patient market trends.

Guide to AI and machine learning medical device regulation, covering FDA AI/ML policy, PCCPs, SaMD classification, 510(k), De Novo, EU MDR, and Good Machine Learning Practice.

CAPA guide for medical device quality systems, covering FDA QMSR, ISO 13485 clause 8.5, root cause analysis, CAPA steps, effectiveness checks, and common audit findings.

Guide to DHF, DMR, and DHR documentation for medical devices, including FDA requirements, ISO 13485 equivalents, record contents, relationships, and practical implementation.

Medical device supplier quality guide covering FDA and ISO 13485 purchasing controls, qualification, audits, agreements, risk controls, and MDSAP expectations.

Step-by-step guide to finding and selecting predicate devices for FDA 510(k) submissions — search strategies, substantial equivalence criteria, split predicates, and common selection mistakes.

The complete guide to CE marking medical devices under EU MDR — classification, conformity assessment routes, Notified Body selection, technical documentation, and step-by-step process.

Step-by-step guide to searching the FDA 510(k) database — finding predicate devices, reading clearance summaries, using openFDA API, and leveraging 510(k) data for regulatory strategy.

The complete guide to FDA Class I medical devices — general controls, 510(k) exemptions, GMP requirements, device listing, and what 'low risk' really means for regulatory compliance.

Everything you need to know about FDA Class II medical devices — special controls, 510(k) requirements, exemptions, device examples, and how to navigate the regulatory pathway.

The complete guide to FDA Class III medical devices — PMA applications, clinical trial requirements, pre-amendment devices, user fees, and what makes Class III the highest-risk regulatory category.

Guide to FDA De Novo classification, including when to use the pathway, application requirements, special controls, review timelines, and how De Novo creates future predicates.

How to search, interpret, and use the FDA MAUDE database — report types, data fields, search techniques, limitations, and practical applications for regulatory professionals.

Use FDA product codes to confirm device classification, regulation numbers, 510(k) exemption status, and the likely premarket pathway.

A detailed comparison of ISO 13485 and ISO 9001 — clause-by-clause differences, regulatory requirements, when you need each standard, and how to transition between them.

Everything you need to know about IVD device regulations — FDA classification, EU IVDR classes A-D, performance evaluation, companion diagnostics, LDTs, and global regulatory requirements.

Learn FDA Section 524B cybersecurity expectations for medical devices, including SBOMs, threat modeling, premarket evidence, vulnerability management, and EU MDR alignment.

Compare FDA PMA and 510(k) pathways by evidence requirements, review timelines, costs, post-market duties, and decision criteria for US market entry.

How to register medical devices with China's NMPA — classification, documentation, clinical requirements, testing, timelines, costs, and practical guidance for market entry.