Introducing the Cloud eQMS Solution for Confluence

Why Confluence?   Or perhaps the first question should be – why quality management? Most medical device companies need to have a compliant quality management system in place to assure consistent quality of their product. Quality management system consists of a number of written procedures and a multitude of records that will be generated during […]

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Relationship between FDA & ISO 13485

The relationship between the FDA and ISO 13485 goes back a long time. The ISO standard has been in the list of General Consensus Standards since the dawn of times, but there has never been a full alignment between 21 CFR 820 (QSR) and ISO 13485. It’s like these couples that have been together forever, […]

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