Make collaboration stronger
Did you know that EngiMed and Covartim collaborate since a long time in a respectful a partnership ? Accepting me as COO of Covartim, Kyun Thibaut give me the opportunity to make this link stronger than ever. EngiMed and Covartim have put in common their resources, building a collaborative Quality Management System documentation that is […]
Birds leave the nest
Sahar has joined the forces of one of our customers. Sure she will continue to ease the implementation of the Quality Management System and bring her good mood to the team. I wish her full success.
ISO22000
Wow, it’s been a long time since we’ve given you some news. Our Quality Management System has been adapted to fulfil the requirements of the ISO2200 on Food Safety Management. Feel free to contact us in case you need an easy way to implement rapidly a quality management system in your organization. (medical devices, in […]
Notified Bodies MDR
We would like to share our experience with the Notified Bodies that have been contacted for a CE marking under the MDR. BSI (UK) and DEKRA (DE) don’t take new customers. TUV Süd indicates they need some time but they expect to be ready beginning of 2020. IMQ (IT) cannot be contacted. TUV Rheinald is […]
EngiMed Team is growing
Very happy to have Julie Humblet joining EngiMed for an interim mission. Julie will give a welcome boost for the transition of the Quality Management System towards the MDR requirements (PMS, PRRC, Vigilance…).
Notified Bodies websites
Maybe this list may help you a little bit: TÜV Rheinland LGA Products GmbH ; https://www.tuv.com/world/en/eu-medical-device-regulation-mdr-2017-745.html DEKRA Certification GmbH ; https://www.dekra-certification.de/medical-devices-manufacturers/regulation-on-medical-devices.html IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. ; https://www.imq.it/en/eu-directives/regulation-medical-devices-mdr TÜV SÜD Product Service GmbH Zertifizierstellen; https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation BSI Assurance UK Ltd; https://www.bsigroup.com/en-GB/medical-devices/our-services/ce-marking/
Symbols
The new Regulation requires manufacturers to add new information on the label: the fact that the device is a medical device, that the device contains materials of animal origin… The MedTech Europe has published a guideline. The proposed symbols are not yet official. We can hope they will be incorporated in the revision of ISO […]
21 August 2019
There are now 4 notified bodies for the Medical Devices Regulation: BSI (UK), DEKRA (DE), TUV Sud (DE) and IMQ (IT). BSI wrote that they accept new applications but it seems that priority is given to existing customers. The list of notified bodies is available on the NANDO website.
