What are Product Review Requirements as per ISO 13485
The purpose of the requirements review related to the product is to make sure companies keep to a high standard when it […]
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Infrastructure requirements in ISO 13485
Infrastructure in ISO 13485 is meant workspaces, process equipment, buildings, etc. Said in other words, to manufacture, design, or supply any medical […]
Read moreThere is a better way to organize your folders!
Small businesses collect numerous kinds of information – financial, employees, customers, vendors, etc. Traditional file organization describes storing data in paper files, […]
Read moreFrom paper-based to eQMS – Problem naming files
Sustaining a paper-based quality management system is pretty hard and time-consuming since it takes a lot of energy to find the essential […]
Read moreRisk 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, […]
Read moreWhat 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 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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