Maintaining a Quality Management System (QMS) usually requires strong efforts from the resources of medical device manufacturers. This will explain the necessity to implement an efficient and simplified QMS in order to ensure proper design control, production, storage and distribution of the medical device as well as supplier management.

From 31st of March 2019, the harmonized standard EN ISO 13485:2016 will replace EN ISO 13485:2012 and shall apply for medical device manufacturers to demonstrate the compliance to the applicable regulatory requirements and the quality and safety of the medical device.

In order to optimize and simplify your QMS, our QA/RA Experts can help you with the following:

  • Initial internal audit (pre-assessment of the actual QMS)
  • Proposition of QMS documentation modifications (new QMS process map, simplification of QMS documents, detection of critical areas)
  • Coaching for the QMS documentation modifications
  • Organization of the necessary training