Regulation
Food products and nutraceuticals
Food products and nutraceuticals
Pharmaceutical products
Pharmaceutical products
Cosmetics
Cosmetics
Animal nutrition
Animal nutrition
Biocides
Biocides
Dispositifs médicaux

Pharmaceutical products - Medical devices

A medical device is “any instrument, apparatus, appliance, material or other article (…) which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means”, used to:

  • Diagnose, prevent, monitor, treat or alleviate a disease or injury
  • Investigate, replace or modify the anatomy or a physiological process
  • Control conception

Medical devices are regulated by Directives 93/42/EEC and 2007/47/EC.

icone-mainThe regulatory framework is currently being reviewed. The new European regulation (which will repeal Directives 93/42/EEC and 2007/47/EC) should be come into effect by mid 2017.

Pharmanager Development assists you with:

  • Developing new medical devices
    • – Oppotunities for new markets
    • – Product characterization
  • Regulatory and scientific assistance
    • – Assessing the regulatory status of your product and determining its class
    • – Assessing the feasibility of your project
    • – Scientific assistance and clinical evaluation
  • Strategic assistance for obtaining certification
    • – Preparing the technical documentation
    • – Selecting the procedures for evaluating compliance
    • – Drafting the specifications
    • – Putting together, tracking and following up your application