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 hand-off must be attributable, time-stamped, and retrievable on demand. ISO 13485 requires that quality records demonstrate who did what and…
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 procedures that support it, and describes how QMS processes interact with each other. Where a manufacturer legitimately excludes a clause…
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 your SOPs, design records, and quality documents are versioned, approved, and retrieved is often the deciding factor between a clean…
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 timeline. It must define development stages, assign responsibilities, identify review and approval points, and establish how groups with different technical…
