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Medical Device Directive

The Medical Device Directive ensures that medical devices are reliable and safe. Medical devices are classified based on their use and risk.

A medical device is defined as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • Investigation, replacement or modification of the anatomy or of a physiological process,
  • Control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means.

Keystone Compliance assists manufacturers in Medical Device Directive compliance by:

  • Assisting with the creation and completion of technical documentation
  • Reviewing risk assessment documentation
  • Determining quality system compliance to ISO 13485

Please contact us to discuss how we can assist you with your Medical Device Directive needs.

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