Medical Devices

Callisto Consulting can support you in:

  • Guidance on the appropriate legislation covering these products in different markets.
  • Classification advice.
  • Provide advice on data requirements and the regulatory activities required.
  • Liaise with the regulatory bodies where appropriate.
  • Submit and manage any regulatory applications that are required.
  • Prepare technical files and support approval by Notified Bodies where needed.
  • Medical Device market surveillance including Incident Reports and Field Safety Corrective Action.

medical devices

Complete range of regulatory services. Extensive experience of human and veterinary medicines, herbal medicines, borderline products, food supplements and cosmetics.

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