Metecon GmbH of Mannheim at MEDICA 2020 in Düsseldorf -- MEDICA - World Forum for Medicine
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Metecon GmbH

P7, 13, 68161 Mannheim
Germany
Telephone +49 621 12346900
Fax +49 621 12346929
info@metecon.de

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Contact

Jörg Ohmer

Head of Business Development

Phone
+49 621 123469-14

Email
joerg.ohmer@metecon.de

Reiner Hübenthal

Business Development

Phone
+49 621 123469-039

Email
reiner.huebenthal@metecon.de

Dunja Schildge-Reichmann

Expert IVD

Phone
+49 621 123469-043

Email
dunja.schildge-reichmann@metecon.de

Dr. Roland Prestel

Head of Medical Scientific Affairs

Phone
+49 621 123469-053

Email
roland.prestel@metecon.de

Stefan Kemmann

Expert International Regulatory Affairs

Phone
+49 621 123469-048

Email
stefan.kemmann@metecon.de

Thorsten Stumpf

Expert Medical Device Software (RA)

Phone
+49 621 123469-27

Email
thorsten.stumpf@metecon.de

Dr. Kerris Klug

Expert IVD

Phone
+49 621 123469-041

Email
kerris.klug@metecon.de

Alexander Fink

Managing Director

Phone
+49 621 123469-11

Email
alexander.fink@metecon.de

Christina Fink

Marketing & Communications

Phone
+49 621 123469-18

Email
christina.fink@metecon.de

Visit us

Unsettled / NN

19.11.2020

Topic

10:00 - 10:30

Clinical data: Is compliance in conflict with economic interests? - LIVE-WEBSESSION

Increasing regulatory requirements typically result in uncertainty and extensive documentation, which together leads to considerable cost and limited further benefit when the approach is solely to meet the minimum.
Cross-functional clinical thinking instead focuses on highly relevant topics, thereby enabling better control of business risks and costs while still fulfilling regulatory requirements.

Speaker: Dr. Roland Prestel, Head of Medical Scientific Affairs

Registration via https://events.medica.de/de/veranstaltung/ws-clinical-data-is-compliance-in-conflict-with-economic-interests

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12:00 - 12:30

Digitize with an edge: Digitization of RA-Processes – the missing link - LIVE-WEBSESSION

The digitization of regulatory affairs processes is inevitable. Appropriate solutions are available, but selection, adaptation and configuration have often proven to be insurmountable hurdles for the manufacturers of medical devices and IVD. This is where we come in - with DigiLab. We have already taken the first steps to digitized RA workflows for you and are your headstart to digital workflows!

Speaker: Alexander Fink, CEO

Registration via https://events.medica.de/de/veranstaltung/ws-digitize-with-an-edge-digitization-of-ra-processes-the-missing-link

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Our range of products

Product categories

  • 06  Information and communication technology
  • 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

Reports and analyses

  • 07  Medical services and publications
  • 07.04  Education

Education

  • 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

Our products

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

RA-DigiLab: Headstart to Digital Workflows - come, try, digitize

Which software fits your regulatory affairs workflows? Let's find out together! We support you throughout the entire digitization process - from selection to implementation. With comprehensive market analyzes, guided selection and test processes and efficient implementation strategies. Visit our DigiLab in Mannheim.

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

Documentation and market access

Consulting services and support for the preparation of technical documentation and filing of your product file.

Technical Documentation
Strategic consultation and active support for the preparation and maintenance of technical documentation

Clinical Affairs
Clinical evaluation via the literature route, clinical investigation, performance evaluation for IVDs, PMS and PMCF / PMPF

Regulatory Affairs
Consulting services and support for country-specific commercialization

Quality Management
Quality Management processes in compliance with EN ISO 13485, GxP; audits

Medical Device Software
Consulting services and support in all regulatory tasks regarding software

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

Verification and validation

Everything about assessing and evaluating your products: starting with development of suitable test strategies right through to testing in the test laboratory.

Verification
Verification planning, preparation of test specifications, conduction and documentation of tests, organization and controlling of examinations in accredited laboratories

Validation
Validation of measuring and inspection tasks incl. software, validation of medical devices / IVDs incl. software, validation of steril processes

Testautomation
Flexible test automation by means of a six axis robotic system, conduction of experimental runs

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About us

Company details

Metecon GmbH advises and supports the manufacturers of medical devices and in-vitro diagnostics with their documentation and regulatory approval as well as with their product testing needs. In addition, Metecon has developed a unique way to support clients with the digitization of their RA processes.

Metecon accompanies manufacturers throughout the entire development process with all necessary supplementary services for technical documentation, verification and validation, medical software, clinical affairs, quality management and regulatory affairs.

The Mannheim based company now has 40 permanent employees - all of them experts in their respective fields with backgrounds in either medical technology engineering or the natural sciences.

The company is certified according to DIN EN ISO 13485.

Alexander Fink, founder and managing director of Metecon GmbH, advocates a new type of collaboration: guided self-management. Management and all employees collaborate on new, meaningful ways of working together, which allows everyone in their various roles a way to react faster in projects, creates more organizational options within the company and ultimately leads to a higher degree of job satisfaction. The "TOP JOB Employer 2020" award shows that Metecon is on the right track with this approach.

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Company data

Sales volume

1-9 Mio US $

Number of employees

20-49

Foundation

1999

Area of business

Medical Services and Publications

Company information as a PDF file