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.

The definitive Stanford textbook on medical device innovation. Covers the full biodesign process from need identification and concept development through regulatory strategy, reimbursement, and commercialization. Required reading for every MedTech entrepreneur.

Clayton Christensen applies his disruptive innovation framework to healthcare. Essential reading for medical device executives and entrepreneurs seeking to understand how to build transformative healthcare companies and navigate market disruption.

The most influential sales methodology of the last decade. Proven especially effective for complex medical device sales to hospitals and health systems. Teaches reps to challenge customer thinking and drive consensus in complex buying committees.

Former FBI hostage negotiator Chris Voss reveals field-tested negotiation tactics essential for medical device sales, contract negotiations, and hospital system deals. The most practical negotiation book for healthcare industry professionals.