Experts Training



  • EN 62366: Usability Engineering 

This training provides the participants with the knowledge and basic skills required to plan, launch and control a Usability project.
Kim Rochat, Senior Partner of Medidee, delivers this training.
Training Brochure

Next session
Coming soon! - 9h-17h
at Medidee Lausanne Training Room.

Contact us to register or for more information

 

  • Active Medical Devices – Requirements – What needs to be considered

This seminar will help you to understand the process for CE-Marking and the correlation between Standards referenced in IEC 60601- series.
Moreover, Ralf Gasser will share his expertise of >20 years of testing of active devices with you and discuss mayor shortcomings and failures manufacturers are facing.

This training will be provided in German.

For more information look at the corresponding Training Brochure.

Next session: Coming soon!  

Contact us for more information

 

  • EN 62304: Software Lifecycle

In order to well address the regulatory requirements that apply to all software contained in a medical device or which are medical device in their own rights, Medidee is providing a specific training on software design, verification, validation and on how to prepare the appropriate documentation for the technical file. This training also presents the necessary processes to implement within the Quality Management System in order to comply with the requirements of the IEC 62304.
 
Kim Rochat, Senior Partner of Medidee, delivers this training.
Training Brochure

Next sessions:

7 & 8 .09.2017 in Copenhagen, Medico Industrien Link for registration & Information

 

 

Clinical, RA and QA Training


  • Internal auditor of QMS & Supplier Audit

This training program is structured around a single intensive day including:

- theory on organization and methods

- practical training in role plays

- Key aspects of Supplier Audit

This program allows for preparing internal compliance auditors for ISO 9001, ISO 13485, ISO 17025, ISO 15189.
Eloïse Oreiller & Chloé Fattebert, Senior Associates of Medidee, deliver this training (in French or in English).
Training Brochure

Next session:

08.11.2017 - 9h00-17h00 at Biopole SE-A

Contact us to register or for more information


  • Revision of ISO 13485 - what Medical Device Manufacturers need to know
Half day training focused on the impact of the changes to this  important QMS standard. 
The aim is also to build awareness of upcoming changes of the regulatory environment linked to ISO 13485 (Medical Device Regulation & MDSAP).
Targeted for RA&QA responsible persons.
Michael Maier, Senior Partner of Medidee, delivers this training. 

Training Brochure

Next session
Autumn 2017 - Date coming soon.

Contact us for registration or for more information

 

  • CARAQA - First CAS in Clinical, Regulatory and Quality

Developed together with HEIG-VD, The School of Business and Engineering Vaud, this 35 days Certificate of Advanced Studies program prepares recognized MedTech professionals for the growing challenges of Medical Devices and IVD market access. 

Integrating theory, case studies and personal projects, the CARAQA CAS trains hands-on, management capable specialists who will play a key role in their startups and confirmed MedTechs. 

Training Brochure - specific page on HEIG-VD website - Study plan

Next session:
Starting September 2017
at HEIG-VD Yverdon - Professor Didier Maillefer
+41 24 557 64 14 didier.maillefer@heig-vd.ch