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Metecon GmbH
P7, 13,
68161
Mannheim
Germany
Germany
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Contact
Dunja Schildge-Reichmann
Expert IVD
Dr. Roland Prestel
Head of Medical Scientific Affairs
Stefan Kemmann
Expert International Regulatory Affairs
Thorsten Stumpf
Expert Medical Device Software (RA)
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Visit us
19 Nov 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
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
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
Speaker: Alexander Fink, CEO
Registration via https://events.medica.de/de/veranstaltung/ws-digitize-with-an-edge-digitization-of-ra-processes-the-missing-link
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
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.
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
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
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
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
About us
Company portrait
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.
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.
Company data
Sales volume
1-9 Mio US $
Number of employees
20-49
Foundation
1999
Area of business
Medical Services and Publications
