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Man with outstretched hand. Product takeover.

QMR, PRRC and authorized representative — we take over for you.

Long-term success requires qualified managers. This also requires know-how and manpower. You get both from us. We support you in setting up, implementing and monitoring the processes and tasks you need by deploying qualified personnel specifically for you. To do this, we integrate our employees into your corporate structure, whether on a transitional or long-term basis.

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You can transfer the following roles in connection with standards and guidelines to us:

QMR

The Quality Management Representative is particularly important for products that are subject to ISO 13485. In this case, he is the “master” of the processes required by the standard.

The tasks therefore include:

  • Review of missing or inadequate processes and, if necessary, the introduction of them (e.g. CAPA, training, complaint, vigilance)
  • Implementation of software tool validation
  • Supplier management
  • Review of procedural instructions and, if necessary, supplement them
  • Ensuring that processes are being followed across the organization
  • Preparation of audit plans and monitoring of audits
  • Assistance in preparing the quality management manual and writing the quality policy

In addition, the QMR is the link between your management and the QM system. They provide regular updates and can encourage improvements.

Quality Management representative at work
Woman advising her customers

PRRC

The MDR also requires a Person Responsible for Regulatory Compliance, or PRRC for short, who complements the tasks of the Quality Management Officer.

Responsibilities include:

  • Ensuring compliance of medical devices
  • Review and, if necessary, adjustment of technical documentation
  • Issuance of the EU conformity assessment statement
  • Compliance with post-market surveillance obligations
  • Compliance with reporting requirements (PMS and trending) and reporting requirements in vigilance cases
  • Explanation of investigational products for clinical trials

In both roles, not all tasks have to be carried out by a single person, but can also be delegated. However, the QMB and the PRRC remain responsible.

Representative

The authorized representative is considered to be the manufacturer's representative in the EU. They are in regular contact with national authorities, are responsible for answering questions and supporting corrective measures.

The duties of the authorized representative also include:

  • Review of the EU compliance regulation
  • Product and manufacturer registration verification
  • Forwarding complaints from users to the manufacturer
  • Contact person for authorities in Europe
Consulting medical technology