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.

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…).

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.

Newsletter juin 2019

You have now free access to the GMDN database -> click here . This codification is used world-widely. Despite it comes a little bit too late for the European Commission that has selected the Italian codification (CND) as part of the future Eudamed database, it could be useful for you to confirm the GMDN code of your products. Indeed, the CND nomenclature will be mapped to the GMDN.

Newsletter April 2019

End of 2018, a new version of the Field Safety Corrective Action and the Manufacturer Incident Report has been published by the Competent Authorities. The templates could be found here. You probably make reference to these documents in your Quality Management System (Vigilance process). Make sure you have the latest version available. A set of procedures and forms is available at EngiMed. Don’t hesitate to contact us.

Newsletter Mai 2019

The new Medical Device Regulation (MDR) in Europe requires the manufacturer to keep records during 10 years (15 years for the implants). Previously (MDD), this retention period was only 5 years. Impact : you have probably documented this retention period in your Quality Management System (in your procedures or in the documents list). Update your documents. Verify also your contracts with distributors or subcontractors. They have also to keep some records. Retention time must be documented (and updated accordingly).