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Clinical trials with medical devices

Now, with the 4th revision of the Guideline, the requirements for the evaluation, testing and certification of medical devices have increased significantly. Specifically, the Guideline now describes, in very much more detail, how and over what period of time a clinical assessment is to be conducted. In addition, specifications regarding the data collection and literature search are given. A significant modification is the compulsory handover of the assessment protocol that describes the methods used in the clinical evaluation and the steps performed. In addition, the room for interpretation in the use of data of a comparison product is significantly reduced by the Guideline’s revision.

In the framework of the certification of your medical device, our team of scientists and physicians is available to you as a competent service provider for clinical evaluations, and as a ‘Think Tank’. Our support ranges from well-designed, scientific studies on the conduct of literature searches to the creation of experts‘ reports or concept papers. It is especially in the case of semi-solid topical formulations for application to the skin or in the eye that our many years of experience in dermatology and ophthalmology excels.

Examples of this are artificial tears for application in the eye and products for the improvement of the skin barrier.


Experience

More than 15 projects with more than 700 patients

  • 21Day Cumulative Patch Test
  • Anti-Transpirant – Hotroom (ATH)
  • Atopic Dermatitis
  • Back Pain (Heat Pad)
  • Blepharitis
  • Cold sore
  • Dry throat
  • Eye Tolerability
  • Laser
  • Scratch Test
  • Warts
  • Wound Healing

Risk classification of medical devices

The proderm guide to risk classification of medical devices.