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
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]
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
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?
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
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?
WS11 - Ecosystem MedTech in near countries
The final TRL Booster MedTech’ s workshop of December will offer the opportunity to meet French, German and Switzerland delegates from MedTech clusters.
These three countries count among the biggest and the best European country active in medical technology market.
More detail soon...