26/04/2022 @Val Benoît - Liège.
WS1 - Regulatory Pathways & Medical Device Regulatory 

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  • Medical Device Regulatory Framework
  • EU legislation & history
  • MDR objectives & economic operators
  • Intended purpose & classification
  • Harmonized standards & guidances
  • Label & instructions for use
  • UDI & EUDAMED
  • Intro on clinical evidence & post-market activities
  • Intro on technical documentation

19/05/2022 - @CEI2 -  Rue Louis de Geer 6, 1348 Ottignies-Louvain-la-Neuve
WS2 - Quality Management System

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  • QMS (MDR – ISO13485)
  • Management responsability
  • Resources management
  • Product realization
  • Measurement, analysis and improvement
  • Certification
  • Tactical implementation

08/06/2022 - @Burogest - Avenue des Dessus-de-Lives, 2 - 5100 Namur.
WS3 -  Design & Development ISO13485  & Quality Risk Management ISO 14971 

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  • Medical Device lifecycle
  • D&D Outline stages of the design and development process 
  • QRM : Links between ISO 13485 and ISO 14971
  • QRM: Outline stages of the risk management process 
  • Tactical implementation. 

21/06/2022 -  @Awex - Avenue des Dessus de Live 6 - 5100 Namur

WS4 -  GSPR / Product requirements & sub contractor selection

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  • Product requirements – from idea to product
  • GSPR checklist – purpose & examples
  • Concept of harmonized standards. 
  • How to leverage standards to show complaince with GSPR
  • GSPR requiring specific attention
  • Sub contractor selection – obtain what you want
  • Dealing with suppliers and subcontractors.

20/09/2022 -   @Awex - Avenue des Dessus de Live 6 - 5100 Namur 

WS5 - Clinical Evidence & Clinical Evaluation

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  • Clinical evaluation process
  • Changes brought by MDR
  • Clinical evidence – what does it include, from marketing survey to RCT ?
  • Clinical investigation & ISO14155
  • Clinical investigations tactics
  • Guidances & GSPR
  • Application to my product


[We advise to follow Workshop 6 also, because both are take in account together by the notified body] 

27/09/2022 -  @Val Benoît - Quai Banning 6 - 4000 LIEGE


WS6 - Post-Market Surveillance & materiovigilance

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  • Requirements for PMS, PMCF, PSUR, SSCP
  • Defining a PMS/PMCF plan
  • Balancing between pre and post-market clinical studies.


[We advise to follow Workshop 5 also, because both are take in account together by the notified body] 

11/10/2022 - @Val Benoît - Quai Banning 6 - 4000 LIEGE
WS7 -   Software as a MD & embedded software

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  • Classification rules (MDR, IEC62304, FDA)
  • Special attention points for risk analysis
  • Harmonized standards & guidances
  • IEC62304
  • Design & Development
  • Release and deployment
  • Post Market requirements
  • Control and change control


25/10/2022 @Burogest - Avenue des Dessus-de-Lives, 2 - 5100 Namur. Salle "Le Loft"
WS8 - GDPR & Cybersecurity

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 Training session content #1: Data Privacy 

  • Introduction of Data Privacy principles and Personal Data
  • Legal aspects to take into account when collecting healthcare-related data
  • Review of the principles, rights and procedures
  • How to manage patient request?
  • Role of the Data Protection Officer
  • Comparison between GDPR and main other international laws (HIPAA, PIPEDA etc.)
  • Rules of international Data Transfers
  • Impacts of Data Privacy for the collect and processing of personal data
  • Key steps to follow for a successful data privacy implementation program
  • Risks and penalties under non-compliance


Training session content #2: Data Security 

  • Usual security challenges faced by healthcare organizations
  • Overview of Good security practices 
  • How to limit data hacking, protect IT systems and make it “user friendly”
  • Data safety and confidentiality: how to minimize the risk of intrusion and  identification?
  • How to manage a Data Breach under current data protection law?

15/11/2022 @Val Benoît - Quai Banning 6 - 4000 LIEGE - Salle Ben Ahin

WS9 - Notified Bodies / AFMPS

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  • The map of stakeholders. Competent authorities vs Notified Bodies vs Certification Bodies. Respective roles and involvement in Conformity Assessment
  • Comparaison with US stakeholders map
  • Current Notified Body landscape: the demand vs offer problem
  • Tactics when dealing with Notified Bodies
  • European Notified body representatives invited during the WS 

23/11/2022 @The Labs - Rue du Bois Saint-Jean 15/1 - 4102 Seraing
WS10- Certification in other countries (US, Asia, Japan) 

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  • US: deeper dive
  • Australia, Canada
  • UK (Brexit): the specific impacts
  • Swiss (Swixit): the specific impacts
  • China: overview
  • MDSAP: principles. Interesting or not? When?

07/12/2022 -  @Ecolys 

WS11 - Ecosystem MedTech in near countries

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The final TRL Booster MedTech’ s workshop of December will offer the opportunity to meet French, German, Switzerland and UK delegates from MedTech clusters. 


More details