The MDD offers a choice of alternative conformity assessment routes in order for a medical device manufacturer to demonstrate product compliance with the essential requirements. The most commonly applied route is in accordance with Annex II, i.e. a full quality assurance system. For a start-up company the minimum requirements of a so called MDD certified quality system may suffice for a period of time but in the long run a quality management system in accordance with ISO 13485 is usually the strategy of choice.
The primary objective of an ISO 13485 certified quality management system is to ensure that the company complies with regulatory and statutory requirements. A well-adapted quality management system though has the potential of becoming a very effective tool especially during product development to keep track on time-schedule, project budget and product quality.
Gidac has a strong understanding of how to merge the regulatory and statutory requirements into practicable processes in key process areas resulting in competitive advantages.