26/04/2022 @Val Benoît - Liège.
WS1 - Regulatory Pathways & Medical Device Regulatory
- 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
- QMS (MDR – ISO13485)
- Management responsability
- Resources management
- Product realization
- Measurement, analysis and improvement
- Tactical implementation
08/06/2022 - @Burogest - Avenue des Dessus-de-Lives, 2 - 5100 Namur.
WS3 - Design & Development ISO13485 & Quality Risk Management ISO 14971
- 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
- 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
- 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
- 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
- Classification rules (MDR, IEC62304, FDA)
- Special attention points for risk analysis
- Harmonized standards & guidances
- 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
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
- 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)
- 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