The Medical Device Professional's Resource Store

A step-by-step practical guide to implementing ISO 13485:2016 Quality Management Systems for medical devices. Essential for quality engineers, regulatory consultants, and anyone pursuing ISO 13485 certification.

The definitive third edition reference for FDA regulatory affairs professionals. Covers 510(k), PMA, De Novo pathways, QSR compliance, and post-market obligations for medical devices, drugs, and biologics.

A practitioner's guide to navigating FDA's Quality System Regulation under 21 CFR Part 820. Covers management controls, CAPA, complaint handling, and audit readiness in plain, actionable language.

The gold-standard reference on FDA design controls for medical device development. Covers design history files, design verification and validation, and 21 CFR 820.30 compliance in exhaustive detail.

An authoritative reference for medical device R&D covering EU MDR 2017/745 requirements, technical documentation, clinical evaluation, and notified body interactions.

A comprehensive guide to preparing and submitting FDA 510(k) premarket notifications. Covers substantial equivalence arguments, predicate device selection, and submission strategy.