Medical devices include a variety of instruments, apparatus, equipment and materials as well as substance preparations or other items that are intended for medical purposes.

The regulatory path for CE-marking medical devices is sometimes challenging and needs customized strategies which suit the device classification. Given our expertise we can provide you with the appropriate regulatory strategy for all life-cycle stages of your product.

We were able to apply our knowledge during the last years in a broad variety of medical fields and device types as well as technologies.

A selection of non-active and active medical devices we supported on the way to reach marketing authorization:

  • Non-active devices, e.g. Surgical Instruments and Implants
  • Various types of active devices
  • Embedded and stand-alone software – medical device software (MDSW)
  • Substance based medical devices – borderline products
  • Combination products incorporating drugs and/or components of animal origin or Combination products for administration of drugs (Drug Delivery Systems)