Formations et événements

The presentation will identify the changes brought by the MDR, focusing on the independent obligations of distributors but also how they relate to other economic operators for MDR compliance. It will address the requirements imposed by the MDR both in the pre-marketing and the post-marketing phases and is primarily intended for all economic operators distributing medical devices in the European Union.

French version of the training will follow soon

All medical devices companies process personal data. Since the adoption of the General Data Protection Regulation (GDPR) in May 2018, businesses are facing many challenges and must adapt their data protection practice in order to avoid significant fines imposed by authorities in case of non-compliance or data breaches. This presentation – focused on the Life Sciences sector – will provide an update on the most recent trends, guidelines and recommendations since the adoption of the GDPR. It will also cover the relevant provisions under the Belgian Act of 30 July 2018 implementing the GDPR. The presentation will finally address some data privacy challenges when using new technologies, such as blockchain

This one day training course on health economic evaluations is specifically oriented to the MedTech sector.

This training session is aimed at those in charge of legal affairs within medical devices companies. It will provide an overview of manufacturers and distributors’ obligations and the main MDR provisions that may impact the day-to-day job of Legal professionals, including in relation to claims / promotion and contracts of different natures.

It is intended for software manufacturers – of all sizes – who would like to know more about their products status, how they qualify under the new MDR rules (is it a medical device or not?) and how they can be classified (in which class does it fall). The training will also provide an overview of the main MDR changes and address a set of basic requirements regarding Medical Device Software beyond qualification and classification.

Réservé membres beMedTech

Save the date- more information will follow soon

This presentation will identify the changes brought by the IVDR and the obligations of economic operators as from 26 May 2022, both in the pre-marketing and post-marketing phases, with tips and tricks to ensure compliance during and after the transition period. This presentation is primarily intended for those manufacturing or distributing IVDs in the EU.

Réservé membres beMedTech