ISO 14971:2019 defines risk management as a systematic process that begins before design inputs are finalised and continues until a device is decommissioned. The standard requires manufacturers to identify hazards, estimate the probability and severity of harm, evaluate whether each risk is acceptable, and implement…
A quality management system is the documented, process-driven framework that a medical device company uses to design, manufacture, and monitor its products. Under ISO 13485:2016, FDA 21 CFR Part 820 (the Quality System Regulation, now aligned to the QMSR), and the EU Medical Device Regulation,…
ISO 9001:2015 is the world’s most widely adopted quality management standard, built on the Annex SL high-level structure that also underpins ISO 13485:2016. For medical device companies, this shared architecture matters: the two standards use compatible clause numbering, common definitions, and the same process-based approach…
ISO 9001:2015 organises its requirements around the Annex SL high-level structure shared by all modern ISO management system standards. That structure groups clauses into context of the organisation, leadership, planning, support, operation, performance evaluation, and improvement. For a first-time implementer, this architecture is both a…
Buying an electronic QMS is not the same as buying software. For a medical device company operating under ISO 13485, FDA QMSR, or EU MDR, the system you select becomes part of your quality infrastructure and, by extension, part of your regulatory record. A document…
Any software that creates, modifies, or controls quality records in a regulated medical device company is subject to validation. Under FDA 21 CFR Part 11 and EU Annex 11, an electronic quality management system (eQMS) is not simply an IT tool. It is a validated…
Medical device quality records carry legal and regulatory weight. A complaint investigation, a CAPA decision, a risk assessment approval, or a 21 CFR Part 11 electronic signature can each be called up in an FDA inspection or a notified body audit, sometimes years after the…
Medical device development projects carry a built-in tension: engineering teams operate on schedules and deliverables, while quality teams operate on procedures and evidence. When these two streams run in parallel, quality becomes a downstream audit of engineering decisions already made. ISO 13485 clause 7.3 and…
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 medical devices, this is not optional. ISO 13485 is the international standard that defines what a QMS must look like…
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 demonstration of regulatory compliance. Additional obligations include design and development controls (clause 7.3), sterile product validation, post-market surveillance under clause…
