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.
Examples of medical devices are prostheses and wheelchairs, wound dressings, medical equipment, diagnostics and implants, but also substances and preparations of materials for use on or in the human body, such as artificial tears or rinsing solutions and many more.
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 accompany you as a competent partner during implementation of the essential requirements in the context of CE-marking for medical devices, in-vitro diagnostics as well as active implantable medical devices. Additionally we can support and advice you as well as coordinate required activities in more specific fields like clinical evaluations or the choice and implementation of conformity assessment routes. Our long experience with, as well as at Notified Bodies will benefit you during the required establishment of systems for risk- and quality management.
Our company is based in Badenweiler, south of Freiburg, from where we operate as an international service provider for regulatory affairs of medical devices and IVD. With our dynamic “hands-on-mentality”, the service of Medical Device plus extends far beyond traditional consulting.
Please see our extensive range of services!