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.
Remote Audit
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....
Risk Management as ISO 14971 requires
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...
Quality Management System
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,...
Supported ISO 9001 and the new clause Hail Mary Pass
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...
Checklist for implementing a QMS for ISO 9001-2015
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...
Things to know before you buy qmsWrapper
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,...
eQMS validation
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...
Data Security
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...
Project & Quality Management System
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...
