Metecon GmbH of Mannheim at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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Metecon GmbH

Q7, 21, 68161 Mannheim
Germany
Telephone +49 621 123469-00
Fax +49 621 123469-29
info@metecon.de

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This company is co-exhibitor of
Forum MedTech Pharma e.V.

Hall map

MEDICA 2021 hall map (Hall 3): stand D92

Fairground map

MEDICA 2021 fairground map: Hall 3

Our range of products

Product categories

  • 06  IT systems and IT solutions
  • 06.08  Other equipment and devices for information and communication technology

Other equipment and devices for information and communication technology

  • 07  Medical services and publications
  • 07.01  Reports and analyses
  • 07  Medical services and publications
  • 07.10  Consulting services for health organisations

Consulting services for health organisations

  • 07  Medical services and publications
  • 07.15  Technical equipment management, test houses / certification bodies

Technical equipment management, test houses / certification bodies

  • 07  Medical services and publications
  • 07.16  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

  • 07  Medical services and publications
  • 07.17  Other medical services and publications

Our products

Product category: Other medical services and publications

Technical documentation: Your ticket to the medical technology market

A medical device always consists of the medical device AND its product file. Regardless of the product classification, whether you want to market a Class I, IIa, IIb or III medical device or an in vitro diagnostic (IVD) device: In any case, technical documentation is required.

The technical documentation contains all detailed information about the medical device. In addition to the actual technical product information, this also includes all information on the development, manufacture, verification and validation as well as the application of the product.

With the help of the technical documentation, you as the manufacturer can prove the conformity of your medical device with the underlying regulations of the individual countries. In addition, it serves as proof of compliance with the basic requirements for the European CE marking. This is a prerequisite for the approval of a product according to the country of destination. The technical documentation must be kept available for inspection by the surveillance authorities for the lifetime of the product, but for at least ten years after it was last placed on the market (15 years for implants).

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Product category: Reports and analyses

Clinical Affairs: For the clinical application of your medical device

Clinical Affairs deals with all questions concerning the clinical application of your medical device. The aim of the activities is to prove that the medical device actually provides the clinical benefit in practical use, which is compared to the risk in risk management. The clinical benefit of the product must be substantiated with data and observed and confirmed throughout the entire product life cycle.

Already in the initial phase of the development of a product, a systematic literature search in incident databases and scientific databases should be carried out as part of a clinical evaluation. On the one hand, this can ensure that known risks from similar products on the market can be excluded for your product, and on the other hand, the current state of the art for this technology becomes clear. These search results then flow directly into the requirements of your product development, and the possible comparative products as well as the clinical data situation of these are already known. In the further development process, a final clinical evaluation is created, which is stored as a central document in the technical documentation and is a mandatory prerequisite for CE marking.

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Product category: Certification and testing of medical devices, quality assurance

Verification and validation

Your goal as a medical device manufacturer is a rapid development process resulting in a shorter time-to-market. By planning design verification early on, you gain the decisive time advantage and reduce your development costs.

When it comes to the testing of electronics, the characterization of sensors or the mechanical stability testing of medical products, we are your experienced partner. The early planning and precise integration of measuring equipment and test stations into your development process is crucial for the efficiency of your entire development process; the use of our freely programmable robot saves you time and money. Together with you, we develop a verification strategy that extracts all the potential from your development process.

The validation of production processes, including the validation of the software used in these processes, is an essential and critical element for the safety and functionality of medical devices. Thus, production facilities and production rooms must be appropriately specified, designed, constructed and tested during planning and construction to ensure that the desired product quality can be reproducibly manufactured. We are happy to support you with the following services.

  • Verification planning based on specification and risk analysis,
  • Creation of the test specification,
  • Planning, execution and evaluation of in-vitro studies and tests
  • and tests,
  • Carrying out tests to verify the product specifications,
  • Validation of measuring and test stations incl. software verification / validation,
  • Validation of medical devices incl. software verification / validation.

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About us

Company portrait

We are the holistic service provider for regulatory market access. We advise and support you in verification and validation as well as in documentation, market access and market monitoring of your medical devices and IVDs.


Sense and purpose of our work

We regularly experience that successful manufacturers of high quality medical devices and IVDs do not see their Notified Body and other surveillance authorities as partners with whom they jointly strive for optimal solutions, but perceive them as a threat. Therefore, we want to enable you, the manufacturers, to communicate with Notified Bodies and authorities as well as with users and patients on an equal footing.

We want to help ensure that the outstanding technical quality of your medical devices and in vitro diagnostics is also reflected in the processes and documentation. We see it as our success if you can concentrate on your technological competence and your processes and documentation allow uncomplicated and rapid market access. The fact that we also reduce your liability risks and increase the safety for your patients and users is another desired effect.