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

Technical documentation for the assessment of conformity

For each medical device manufacturers need to hold the technical documentation. Depending on the devices intended use and risk-classification, specific requirements on technical documentation need to be fulfilled. These result from the applicable standards, guidelines and directives.

Technical documentation contains but is not limited to:

  • Administrative information
  • Intended use and description of a medical device
  • Technical detailed data of the medical device
  • Check lists of essential requirements
  • List of applied standards
  • Risk management, usability and clinical evaluation
  • Instructions for use, accompanying documents and labeling
  • Documented evidence about verification and validation (V&V) of the implementation of product requirements

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.

MedSysCon: CE Kennzeichnung

CE marking

Fulfillment of regulatory requirements

MedSysCon: Technische Dokumentation

Technical documentation

ISO 14971 compliant risk management file

MedSysCon: FDA 510(k) Freigabe

FDA 510(k) Clearance

Legally market your medical device in the US

Your Benefits

Together we will identify the best submission strategy for your medical device. We support your decision-making process and help you with:

  • Conformity assessment
  • Compliance with Essential Requirements (CE-marking)
  • Updating technical files
  • Preparing premarket submissions (510(k), PMA, IDE)
Do you have questions on the subject Regulatory Consulting?

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