Can 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 […]
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if (!is_admin()) { }To have or not to have? To certify or not? You want to produce a medical device. So, you decide to hire […]
Read moreSmall businesses collect numerous kinds of information – financial, employees, customers, vendors, etc. Traditional file organization describes storing data in paper files, […]
Read moreSustaining a paper-based quality management system is pretty hard and time-consuming since it takes a lot of energy to find the essential […]
Read moreISO 13485:2016 requires companies to use risk-based thinking to manage their business. Risk is inherent in all aspects of a QMS. There […]
Read moreIn a fast-paced world, the risks companies are exposed to have to be managed in order to continue to grow and develop, […]
Read moreThe 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 is at the heart of the product development process and is mandated by the medical device standards and guidelines. As traceability […]
Read moreA 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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