QM: meeting all requirements

In Europe, all medical devices are subject to the medical device regulation (MDR) and all in-vitro diagnostics to the in vitro diagnostics regulation (IVDR). These regulations require manufacturers and/or distributors of medical devices to establish and maintain a quality management system (QMS) and have this system audited and certified through a notified body before placing the medical device on the market. Initial certification is followed by annual repeat or monitoring audits. Regulatory requirements of non-European target markets also provide for the establishment of a quality management system (QMS).

All medical devices are governed by the internationally harmonized EN ISO 13485 standard (“Medical devices -- Quality management systems -- Requirements for regulatory purposes”). All requirements of this international standard relate specifically to medical engineering companies that manufacture and/or place on the market medical devices, regardless of the type or size of the company.

Metecon supports you in establishing and maintaining a QMS, in validation, as well as before and during audits and inspections by the authorities. You want to know more about QMS? We are happy to answer all your questions!

IVD quality management

For many IVD manufacturers, the IVDR brings about new requirements for their quality management system. Therefore, when implementing the IVDR as a manufacturer, one of the first steps should be to check the requirements that their QM system needs to fulfill in the future. It needs to be considered for instance that the new version of EN ISO 13485:2016 will become binding in mid-2019.

How may we support you?

We support your quality management for Europe, the US, and other countries with all our energy and expertise.

QM international

Together we establish proof that your documentation and QMS comply with all requirements.

Audits

Fit for the future with the Metecon Academy

Each of our workshops and in-house courses provides sustainable knowledge and know-how in the areas of technical documentation, regulatory affairs and QM and is always exactly tailored to your needs.

Our customers use our workshops with our experts:
to keep themselves and their team up to date with the latest knowledge and/or to go into intensive exchange with us and gain clarity in the face of a current challenge about a specific description of objectives and the project strategy.

Through the operation of our own trainee academy, our comprehensive training material is always up to date.

Let us find out together what your team needs!












Workshop topics:

  • Implementation of IVDR for technical documentation and QM
  • Risk management
  • Usability
  • Biological safety
  • Clinical affairs
  • Software
  • Approval
  • Quality management

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