Risk Management according to ISO 14971
In a fast-paced world, the risks companies are exposed to have to be managed in order to continue to grow and develop, […]
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What risk-based approach to QMS means?
The new version of the ISO 13485:2016 standard expects companies to apply a “risk-based approach” to all their QMS processes, exactly stating they […]
Read moreTraceability Matrix Best Practice
Traceability is at the heart of the product development process and is mandated by the medical device standards and guidelines. As traceability […]
Read moreWriting ISO 13485 Quality Manual – Need a tip?
A quality manual is a document that outlines the company’s intentions for managing processes in quality management. It may include rules for […]
Read moreThe Importance of the Quality Manual in Medical Device Compliance
What Is a Quality Manual and Why Does It Matter? A Quality Manual is the foundation of a QMS—often called the “QMS […]
Read moreStart using eQMS today
For MedTech startups, navigating regulatory requirements and implementing a Quality Management System can be challenging. Establishing compliance processes early on is crucial, […]
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