Your guide
Through the rough waters of the trials,
to the safe harbor of approval.
Technical documentation, quality management and co.
We accompany you on the way to the utilization of your medical device.
We help you through the CE certification of your medical device.
In Europe, before medical devices can be approved and placed on the market, manufacturers must guarantee the safety and performance of their product throughout its lifetime.
The evaluation as well as the demonstration of safety, performance and benefit is carried out based on clinical data in a clinical evaluation and must be continuously assessed through ongoing market surveillance The clinical evaluation is an essential part of the conformity assessment procedure for CE marking for all medical device classes, and is required for every medical device.
The European Medical Device Regulation (MDR) 2017/745 significantly increases the requirements on the scope and quality of the required clinical data. In this context, the collection of own clinical data moves into the focus of the MDR and represents a major challenge for all medical device manufacturers. Without sufficient clinical data, approval of medical devices in Europe is no longer possible. Medical device manufacturers are then obliged to collect their own clinical data as part of a clinical trial.
Through the rough waters of the trials,
to the safe harbor of approval.
MEC-ABC GmbH
Aachener-und-Münchener-Allee 9
52074 Aachen
Tel.: +49 241-51967486
Mail: info@mec-abc.de
The MDR is mandatory from 26 May 2021 after a four-year transition period.
Use our free newsletter about the certification of medical devices under MDR.
Bleiben Sie informiert.
Ihre hier eingegebenen Daten werden lediglich zur Personalisierung des Newsletters verwendet und nicht an Dritte weitergegeben. Sie können sich jederzeit aus dem Newsletter heraus abmelden oder Ihre Einwilligung jederzeit per E-Mail an info@mec-abc.de widerrufen. Ihre Daten werden nach Beendigung des Newsletter-Empfangs innerhalb von 1 Monat gelöscht, sofern der Löschung keine gesetzlichen Aufbewahrungspflichten entgegenstehen. Durch Absenden der von Ihnen eingegebenen Daten willigen Sie in die Datenverarbeitung ein und bestätigen unsere Datenschutzerklärung.
Sollte die Mail nicht in Ihrem Posteingang zu finden sein, kontrollieren Sie bitte auch Ihren Spamordner.
Stay informed.
The data you enter here will only be used to personalize the newsletter and will not be passed on to third parties. You can unsubscribe from the newsletter at any time or revoke your consent at any time by sending an email to info@mec-abc.de. Your data will be deleted within 1 month after you stop receiving the newsletter, provided that there are no statutory retention obligations to the contrary. By sending the data you have entered, you consent to the data processing and confirm our privacy policy.
If you cannot find the e-mail in your inbox, please also check your spam folder.
Das Template-Paket Klinische Bewertung ist für Sie jetzt zum Angebotspreis in limitierter Auflage verfügbar.
Sichern Sie sich unsere Whitepaper zu “Anforderungen der MDR” und “Übersicht über die Konformitäts-Bewertungsverfahren”.
You need to load content from reCAPTCHA to submit the form. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from Facebook. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from Google Maps. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More InformationYou need to load content from reCAPTCHA to submit the form. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from Turnstile. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More Information