Reading List — regulatory affairs & medical device quality

Regulatory affairs fundamentals

The ground-floor texts for anyone new to US medical device regulation, or for sharpening vocabulary.

Fundamentals of US Regulatory Affairs(affiliate link) — Regulatory Affairs Professionals Society (RAPS)
The canonical RAPS text. Expensive, but the reference most RA practitioners own.
FDA Regulatory Affairs(affiliate link) — Pisano & Mantus
Academic-press standard covering drugs, biologics, and devices side by side.
The Medical Device R&D Handbook(affiliate link) — Theodore Kucklick
Practical engineering-meets-regulation perspective from early concept through clearance.

How 21 CFR 820 and ISO 13485 actually work in a product organization.

Design Controls for the Medical Device Industry(affiliate link) — Marie B. Teixeira
Structured walkthrough of 21 CFR 820.30 with practical document templates.
Medical Device Quality Management Systems(affiliate link) — Susanne Manz
Strategy and techniques for improving QMS efficiency — written by a former FDA and industry QA lead.

Making the device do what the labeling claims, documented well enough to survive audit.

Reliable Design of Medical Devices(affiliate link) — Richard C. Fries
Long-running reference on reliability engineering tailored to medical hardware.
Medical Device Software Verification, Validation, and Compliance(affiliate link) — David A. Vogel
Software-as-device and software-in-device, aligned with IEC 62304.

Usability engineering is a compliance discipline, not a UX wishlist.

Usability Engineering for Medical Devices(affiliate link) — Michael Wiklund et al.
The practitioner companion to IEC 62366 and FDA human-factors guidance.

What the clinical file needs to look like, and why.

Clinical Evaluation of Medical Devices(affiliate link) — Becker & Whyte
Methodology for assembling the clinical evidence supporting safety and effectiveness claims.
Medical Device Design: Innovation from Concept to Market(affiliate link) — Peter Ogrodnik
End-to-end development lifecycle with regulatory checkpoints called out by phase.

Suggestions for additions are welcome. The bar is: practitioner-relevant, not a vendor pitch. Email corrections via the alerts signup page.