1 HOUR FREE CONSULTANCY – German Area

Regulatory Check Up

Every second Tuesday of a month

Organized in partnership with:

Since May 2021, the new EU Medical Devices Regulation ((EU) 2017/745 Regulation on medical devices (MDR)) has come into force, and from May 2022, the new EU In-vitro Diagnostics Regulation ((EU) 2017/746 Regulation on in-vitro diagnostic medical devices (IVDR)) will follow it.

 

This will be accompanied by far-reaching changes, including in the classification, clinical testing and quality management of medical devices and in vitro diagnostics.

 

Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.

 

Are all appointment options already taken? Please contact us at the following e-mail address to arrange additional appointments and options: raimo.sump@medidee.com

Benefit from an approximately one-hour personal exchange with experts on your topics such as:

  • Assessment of your regulatory positioning/strategy
  • Assessment of the impact of new European regulations (MDR & IVDR) on your strategy
  • new product classifications and their impact (medical software, IVD, etc.)
  • clinical evaluation according to MEDDEV 2.7/1 rev 4 and MDR/IVDR
  • clinical investigation and clinical performance study
  • PMS and PSUR (Post Market Surveillance and Periodic Safety Update Report)
  • Quality management system requirements from ISO 13485: 2016.
  • Challenges in process validation of manufacturing processes
  • Supply chain management (MAIDS: Manufacturer, Authorized representative, Importer, Distributor, Suppliers)
  • Other questions you may have on Regulatory, Clinical and Quality Systems related to conformity assessment, CE marking or FDA market approval for medical devices.
  • individual consultation

How does it work?

Medical device and in vitro diagnostic companies can sign up for one of the monthly appointments on a regular basis. For targeted preparation, in order to generate as much added value as possible for you in the appointment, we ask you to provide the following information when registering:

  • Name of the company with link to the website
  • Names and position of the participating persons
  • Specific topics/questions
  • In order to discuss your topics and questions with experts individually and in full confidentiality, no third party will be present during each appointment. Please let us know well in advance if you would like a non-disclosure agreement, which we will be happy to sign in advance.

 

Please select one of the remaining available appointment slots (possible slots: hourly from 9:00 a.m. to 4:00 p.m.; available when visible).

 

If you need a different appointment time than available or would like to change your appointment time, please feel free to contact us. We will then try to flexibly accommodate your request.