Medical Devices

Regulation Framework for Medical Devices

Medical device is the inclusive term for all devices, instruments, apparatus, appliance, software, materials or other objects to be used for diagnostic and / or therapeutic purposes. By definition the principle intended action in or on the human body is not achieved by pharmacological, immunological or metabolic action. Medical devices must undergo a conformity assessment procedure in Europe. This conformity assessment procedure differs depending on the specific medical device and risk class.

New medical devices and their manufacturers will be affected by the forthcoming new medical devices regulations, and for many this may be a challenge.

How does DREHM Pharma support you with Medical Devices?

DREHM Pharma provides valuable services to help face these challenges and can be a valuable partner on the road towards success.

Technical documentation

DREHM Pharma evaluates and compares existing documentation with current guidelines and regulations as well as writes new documentation for all conformity assessment procedures.

Issues related to borderline products

DREHM Pharma evaluates borderline products and creates reports to classify and demarcate medical devices.

Regulatory support

DREHM Pharma advises on regulatory issues including label creation, and the release of promotional materials.

Vigilance

DREHM Pharma provides a vigilance system with all necessary facilities and resources, including the recording of incidents and forwarding to the manufacturer and / or authority.

We provide the following services and authorized persons:

  • Qualified Person (after impending Regulation)
  • Appointment of conformity assessment procedures
  • Contact person for the Authorities
  • Post Market Clinical Follow-Up (PMCF) and Post Market Surveillance (PMS)
  • Implementation of the Field Safety Corrective Actions (FSCA)

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