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: