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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
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
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.
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.