Manufacturing, distribution and use of medical devices is regulated by strict legal provisions. Not only do medical devices need to function flawlessly, but they also need to be safe for users and patients. Because of this – and especially for critical and sterile medical devices – a high standard in quality assuring measures is expected. For medical device classes IIa, IIb and III, it is indispensible for manufacturers to establish and monitor a quality management system according EN ISO 13485.

Sound know-how and several years of experience acquired from consulting projects in companies of various sizes and structures – our recipe for making sure that you will have a tailor-made and effective quality management system according ISO 13485 that can confidently stand through authority inspections and customer audits.

Our services:

  • Mock auditing for identification of quality assurance deficiencies and weak points
  • System set-up and practical support with validation and qualification
  • Set-up and optimization of quality assurance systems (e.g. CAPA management)
  • Preparation of new SOPs, harmonization and optimization of existing SOPs as well as consulting and support in SOP implementation
  • In-house seminars and trainings for lasting change towards regulatory compliance