Medical devices

We offer a comprehensive service for medical devices as follows:

  • Design and product development
  • Testing, such as shelf life tracking, physical tests, chemical analysis, microbiology
  • Preparing technical files
  • Risk analysis, reviews and clinical evaluations
  • Preparing biological and chemical evaluations
  • Demonstrating equivalence
  • Certification with the notified body
  • Manufacturing and packaging operations
  • Final inspection and release for sale
  • Product maintenance throughout the product’s life-cycle
  • Vigilance while the product is on the market
  • Acting as the holder of the CE marking on the customer’s behalf

We can offer the full service, from design up to releasing the finished product for sale or individual sub-areas. We operate as required by the ISO 13485 standard.

Our operations currently cover the design, manufacture, final inspection and sales of the following types of medical devices:

  • Medical devices that prevent and reduce gastrointestinal gases
  • Medical devices intended for treating constipation
  • Medical devices intended for treating ears
  • Medical devices intended for protecting skin moisture
  • Medical devices intended for cleaning the face

We can expand the range of product categories in accordance with our customers’ requirements.