Fulfillment of regulatory requirements while simultaneously avoiding over-interpretation.
Are you well prepared regarding the new requirements of the MDR and IVDR? Do you need support for the (pre)market approval of your medical devices? Your company wants to approach new markets?
MedSysCon will assist you to answer these questions and help to find the easiest way for getting your medical devices market approval. We will support you with all regulatory affairs questions to place your medical device into the correct category, to place the product on the market in a timely manner and to maintain a valid state permanently.
Conformity assessment procedure for CE marking
The classification of medical devices according to the 93/42/EEC in its four risk-classes e.g. follows the classification rules of Annex IX of the medical device directive. Depending on the medical device classification several registration procedures are applicable. MedSysCon provides an extensive range of services for the registration of your medical device.
- Identification of product classification
- Development of a suitable approval strategy
- Identification of applicable (harmonized) standards, guidelines and directives
Creation of needed technical documentation for the approval of all medical device classifications
FDA 510(k) Clearance for Medical Devices
Medical device manufacturers of class II medical devices, which want to legally market their products in the US, necessitate an FDA-clearance for their devices.
This process is a submission of documentation according to chapter 510(k) of the Federal Food, Drug, and Cosmetic Act, which allows FDA to determine if the medical device is substantial equivalent to already legally marketed predicate devices in the US. If the evidence of substantial equivalence not obvious to the FDA, the manufacturer might need to obtain a PMA approval instead.
Changing an existing design of a marketed device might also lead to a new 510(k). Further development of the product portfolio should therefore always be performed in close collaboration with regulatory affairs professionals.
MedSysCon offers a comprehensive package for the compilation and submission of your 510(k):
- Analysis of all relevant FDA Guidelines
- Analysis of the respective medical device for classification and identification of the regulation number
- Listing of all required 510(k) documents
- Identification of one or more predicate devices
- Preparation of all relevant chapters of the 510(k)
- Coordination of FDA response
- Support of the 510(k) submission fee payment process
If you currently do not have legally marketed devices in the US, we support you with your Registration and Listing.