Komende opleidingen en events
Public tenders- beginners course- Online session
As (almost) all Belgian hospitals are subject to the public procurement regime in Belgium, hospitals have to use tender procedures to procure their medical devices.
This presentation will give an introduction into public procurement procedures in Belgium focused on the Life Sciences 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 presentation will include a tender documents walkthrough by which the different documents in the tendering process are analysed 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.
The presentation will be followed by a Q&A.
Public Tenders - Advanced-Online session
This presentation 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 presentation 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.
Distribution of medical devices under the MDR- Online session
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.
MDR and Medical Device Software qualification & classification
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.
Health Eonocmic Evaluations for medical devices companies (1/2) Online
This is the first part of the training course on health economic evaluations which is specifically oriented to the MedTech sector.
The second part will be held on 29/10/2020 from 13:00-16:00. You have to register for both sessions.
You will find more information in the brochure.
Health Economic Evaluations for medical devices companies (2/2) Online
This is the second part of the training course on health economic evaluations which is specifically oriented to the MedTech sector.
MDR for legal teams- Online session
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.
Algemene vergadering- Online Microsoft Teams Session
Gereserveerd voor beMedTech leden
The new IVD Regulation for importers and distributors-Online session
This session will give a high level summary of the upcoming IVD Regulation 2017/746.
It will give sufficient information for importers and distributors to understand the issues that manufacturers are facing. Nevertheless, the focus of the session is on the specific impact of the IVD Regulation on importers and distributors. It will address the obligations that the IVD Regulation is directly imposing on importers and distributors : registration requirements, handling and reporting of complaints and incidents, the impact on distribution agreements and on internal procedures, etc...
It will also pay attention to business risks, resulting from the IVD Regulation.
Update on GDPR for medical devices companies- Online session
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