• 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

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

• 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. 

• 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.

• 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] 

• 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] 

• 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

 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?

• 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 

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

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