Need to upgrade your QMS? Our phased approach to ISO 13485 compliance will put you on the path to certification. Our goal is to ensure that all activities related to a successful ISO 13485:2016 quality management system are effectively implemented. We leverage our proven approach for QMS development that combines planning, training, and follow-up consultation. We have been helping companies implement, audit, or get trained on ISO 13485 since it was introduced in 1996. ISO 13485 is the de facto standard for medical device quality management systems (QMS).
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