Komende opleidingen en events
MD software qualification & regulation under the MDR
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.
Medical Devices legislation (MDR & Belgian law)
Public Tenders- beginners course
This training will give an introduction into public procurement procedures in Belgium focused on the medical devices sector.
It will touch upon the applicable legislation and principles, the different actors, the key features of tendering and an overview of the different procedures possible.
This training will include a tender documents walkthrough by which the different documents in the tendering process are analyzed and discussed with practical recommendations.
It will address key elements such as technical minimum requirements, selection criteria, awarding criteria, offer deadlines, e-Procurement, ESPD and much more.
Public Tenders- Advanced course
This training will focus on the current practical problems in tender procedures for medical devices, as well as on recent developments and case law concerning, amongst others, technical minimum requirements, selection criteria and awarding criteria.
In particular, this training will address items such as FAMHP Circular 646 and anti-gift rules, samples, value-based procurement, improvement proposals, commercial secrecy, price revision and much more. It will also touch upon what to do after awarding, where to look in the awarding report and which options are available to challenge awarding decisions.
Health Economic Evaluations for medical devices companies
Towards more value based health care in Belgium?
Our health care system is under great pressure and the COVID-19 crisis makes it even clearer that we need to rethink the current model to ensure a more sustainable, affordable and patient-oriented health care system. The continuous evolution towards a Value-Based Health Care (VBHC) approach will be an essential part of the solution.
During this 2 full days conference, expert speakers will share their knowledge on VBHC, dive into the actual state of play in Belgium and other countries and share their views on the way forward for Belgium.