From idea to qualified product 1

From idea to qualified product

From idea to qualified product

Regulatory Affairs

Having an own Regulatory Affairs Department, GEMÜ is able to help the customer meet national and international regulatory requirements in the early stages of product development. Thus, you can rest assured that your product complies with the latest regulatory requirements.

Qualification and validation

Our certified validation processes provide documented verification that the production of your medical technology product is reliably and permanently guaranteed.

Normative and regulatory basis

With the help of our network of partners we would also be pleased to help you in the following areas:

  • Packaging validation
  • Transport validation
  • Ageing tests
  • Sterilisation validation
  • Biological qualification

From individual production to series production

The process for the optimal cleanroom product

At GEMÜ, projects comprise five phases. The end of each phase represents a milestone; it contains a review as well as the release for the next phase. Customer solutions primarily begin in phase three. If necessary GEMÜ can assist you during phases 1 and 2.

Creator
1
Concept
Requirements for the new product are defined in the user requirement specification. Subsequently, the design and concept variants are created. Patent suitability is clarified, the preliminary regulatory strategy as well as the risk and cost analysis are developed.
Creator
2
Product development
Over the course of detailed project planning, the user requirements specification turns into a functional specification. Once approval is given, the product development begins. CAD data are generated and prototypes constructed. Furthermore, the production process (including audit planning) is being organized. Labelling and packaging of the product are being defined.
Co-Creator
3
Process development
The tools, fixtures and models are designed, manufactured and sampled in the process development phase. Simultaneously, the qualification processes are implemented. Production guidelines are drawn up and staff are accordingly trained. The process development phase finalises when the functional capability of the tools, fixtures and plants is qualified.
Co-Creator
4
Process validation
The proof phase begins with the design, the document freeze and the commencement of change management. Process proof is provided by three validation runs. Therefore, series production parts are manufactured and tested as per process documentation in a batch size that is resembling series production levels. If required, a larger test scope can be set up. Following validation, the product is registered and released for production.
Co-Creator
5
Market launch
After the final project review, the product is to be introduced to the market.
Höchste Reinraum-Qualität

Highest cleanroom quality

Defined and certified quality

Working together with you, GEMÜ defines the requirements for the new product. On that account, the following measures are implemented:

  • Samples are taken from all raw materials, tested for compliance with the required specifications and kept in safe storage for the necessary period of time
  • The facility is subjected to constant monitoring and requalification
  • Qualified operating equipment and validated processes
  • Cleanroom production employees are regularly trained and tested
  • A 100% test can be carried out on the products if required
  • Customer audits are used for optimisation as well as valuable feedback
  • In the interests of traceability, all manufacturing documents and reserve samples are archived according to the defined storage period

GEMÜ Medical promotes innovation with verified market expertise.

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