ISO 13485: 2016 Medical devices - Quality Management Systems. It is interconnected Quality Management software for companies focused on regulatory issues, and quality requirements specific to these companies. Requirements for regulatory purposes EN INGLÉS Miguel Sanson. qmsWrapper is a ready-to-use eQMS for medical device companies. ISO 13485:2016 is the Medical devices Quality management systems standard and it can be bought and downloaded as a PDF from various online sources. eQMS is a system that is very easy to maintain, it makes all information available online to audit easily, and any recent changes can be communicated quickly to all staff members. The industry’s best-practice is implementing electronic quality management. I’ve noticed that the medical device industry is missing an obvious interpretation of the ISO 13485 requirements, so I’ve written this guide and translate the requirements into plain English. A QMS also gives assurance to customers that the requirements for quality have been met. The practice of implementing a QMS is a long-term tactical decision that, once in place, works to guide the medical device company to meet standards constantly, improve general performance, and to provide a basis for maintainable development initiatives. ISO 13485 is an international standard for establishing quality management in the medical device industry.
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