What are the Outputs of Design and Development
The ISO 13485 standard requires the medical device company to define expected outputs in the end of any development stage. Design and […]
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Human resources in ISO 13485
This part of the standard explains how employees whose actions impact product quality that has to be qualified to work on products […]
Read moreCan my medical device be produced by a non-ISO 13485 certified manufacturer?
To have or not to have? To certify or not? You want to produce a medical device. So, you decide to hire […]
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 moreWant to apply risk-based thinking? This you should know
ISO 13485:2016 requires companies to use risk-based thinking to manage their business. Risk is inherent in all aspects of a QMS. There […]
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 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 […]
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