Quality Responsible for Medical Devices
Our services for a Quality Responsible for Medical Devices

If your company is involved in the purchasing, storage, distribution, and/or sale of medical devices or in vitro diagnostic devices in Belgium, you must comply with European regulations (MDR 2017/745 and IVDR 2017/746) as well as specific Belgian requirements.

With a Quality Responsible from Q-support, we can support you in establishing a patient-safe supply chain.

Q-support develops a customized package tailored to your company’s needs, including:

  • Development of a documentation system
  • Infrastructure qualification
  • Personnel training
  • Implementation of operational processes
  • Organization and documentation of complaints, recalls, self-inspections, etc.
  • Materiovigilance management and contact point services
  • Registration with the competent authorities
  • Audit preparation and support for inspections by authorities, customers, suppliers, and other stakeholders

Services

For distributors of medical devices and in vitro diagnostic devices, we offer a dedicated service.

Together with your company, our Quality Responsible develops an appropriate quality system that ensures compliance with both European and Belgian legislation, as well as materiovigilance requirements.

Use our expertise now and elevate your pharmaceutical activities to a higher level.