In regulated medical device organizations, communication is not simply a coordination tool. It is a quality record. ISO 13485 section 5.5.3 requires top management to establish communication processes within the organization and to ensure communication takes place regarding the effectiveness of the quality management system.…
ISO 13485 clause 4.1 requires manufacturers to do more than list their quality procedures. It requires identifying each process that affects product conformity, mapping the inputs and outputs of that process, defining the sequence and interaction between processes, assigning adequate resources, and establishing monitoring criteria.…
Quality managers in medical device companies spend a large part of their day chasing status information that lives in different places. Open CAPAs in one folder, overdue training records in another, pending document approvals in a third. When everything is siloed, preparing for an ISO…
In a medical device quality system, who can view, edit, approve, and sign records is a regulated decision, not just an IT setting. FDA 21 CFR Part 11 expects access limited to authorised individuals and an audit trail that attributes every action to a real…
In a regulated quality management system, every user account is a compliance record. ISO 13485 clause 6.2 requires organizations to document the competence of personnel performing quality-affecting work, assign responsibilities formally, and retain evidence that those assignments were made. A user profile in a QMS…
Software development teams building medical devices or SaMD commonly run two separate systems: Jira for sprint planning, issue tracking, and defect management, and a QMS for quality events, CAPAs, change control, and regulatory records. Each system does what it was built for well. The compliance…
Setting up a QMS for medical device development is not a single project decision. It is a sequence. ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR Article 10 all expect the same baseline before product work begins: a defined scope, documented processes, controlled…
Forms are the most basic record-creating instrument in a quality management system. A non-conformance report, a training completion record, a supplier qualification checklist, a corrective action plan, a product inspection sheet: each is a structured form that a person fills in, signs, and submits. The…
Document management is where a medical device quality system either stays audit-ready or slowly falls apart. ISO 13485:2016 Clause 4.2.3 requires controlled documents, Clause 4.2.4 requires controlled records, FDA 21 CFR Part 820.40 sets the same expectation for document controls, and EU MDR technical documentation…
In medical device regulation, a remote audit follows the same objectives as an on-site visit: verify that the quality management system is implemented and effective. The difference is the medium. Notified bodies conducting ISO 13485 surveillance audits and regulatory authorities reviewing MDSAP submissions increasingly accept…
