Project Planning / Development.

Cooperation

We support or customers throughout the entire project. This includes a professional assessment of the required needs for a detailed project planning & quotation submission.

As a "one-stop partner" for integrated development, production, packaging, documentation and approval we provide support with the necessary competencies, such as validations, concepts and much more.

Our Quality system allows our customers two options:

  • we act as contract manufacturer and our customer as legal manufacturer or
  • that we are in the role of the Legal Manufacturer and set up and maintain the corresponding documentation of the medical device and our customer act as the Distributor (with his own part number system and packaging design as well as logo).

Prototyping

Before series production, we offer a number of options for finalizing the design by prototyping via short track productions runs.

Realization

After we have submitted our quotation and the initial project plan, we start the work based on a corresponding agreement (NDA, QA, SQA...). For this we have strong experts from:

  • Projekt- and Product Management
  • Design- and Production Engineering
  • Regulatory and Quality
  • Legal
  • Marketing

The project can be closed when the contract agreement is met and this can take it all the way to registration in the appropriate countries.

Get in Contact

Product

Contract Manufacturing
Rechtliches
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Komet Medical is not only a contract manufacturer. Komet Medical offers on request a fully approved medical device based on EU-MDR and FDA requirements - on a private label basis. Our customer receives the required product with his order number system and with packaging in his corporate design. However, Komet Medical takes over the role of Legal Manufacturer with all rights and obligations as well as full support for the country registrations.

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