Whitepapers
MedTech quality and regulatory whitepapers
This page provides Medical Tech quality and regulatory whitepapers with practical guidance on quality, risk, design controls, and regulatory compliance for medical device and SaMD companies. The resources include detailed explanations of ISO 13485 requirements, ISO 14971 risk management practices, FDA QMSR expectations, and EU MDR/IVDR considerations, helping QA/RA professionals understand best practices and regulatory obligations across global markets.
QMS for Beginners
A quality management system is a set of interconnected processes, responsibilities, and records that govern how a company designs, makes, and monitors a product. In...
Checklist for implementing a QMS for ISO 13485-2016
ISO 13485:2016 extends the ISO 9001 quality management framework with requirements specific to medical devices. Where ISO 9001 emphasizes continual improvement, ISO 13485 demands consistent...
Team Collaboration
In regulated medical device organisations, collaboration is not simply people working together. It is the coordinated execution of quality activities where every decision, approval, and...
Quality Manual
Under ISO 13485:2016 clause 4.2.2, every medical device manufacturer must maintain a quality manual that defines the scope of the QMS, documents or references the...
Document Management & Control
Document control is the foundation auditors examine first. For medical device companies under ISO 13485, FDA 21 CFR Part 820, or EU MDR, the way...
Project management with qmsWrapper
ISO 13485 clause 7.3.2 requires a documented design and development plan for every product, but the plan must do more than sequence tasks on a...
