WS1 - 26/03/2024 - Regulatory Pathways & Medical Device Regulatory  @BioPark

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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 

WS2 - 23/04/2024 - Quality Management System @BioPark

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

WS3 - 14/05/2024 -  Design & Development ISO13485  & Quality Risk Management ISO 14971 @BioPark

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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. 

WS4  - 28/05/2024 - GSPR / Product requirements & sub contractor selection  @BioPark

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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.

WS5 - 11/06/2024 - Clinical Evidence & Clinical Evaluation @LegiaPark

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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] 

WS6 - 25/06/2024 - Post-Market Surveillance & materiovigilance @LegiaPark

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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] 

WS7 - 02/07/2024 - GDPR & Cybersecurity  @BSLI 

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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?

WS8 - 10/09/2024 - Software as a MD & embedded software  @LegiaPark 

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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

WS9 - 24/09/2024 - Notified Bodies / AFMPS @LegiaPark

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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 

WS10 - 24/09/2024 - Certification in other countries (US, Asia, Japan) @LegiaPark

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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? 

WS11 - 15/11/2024 -  Ecosystem MedTech in near countries

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Program in progress... 

✉️ Keep me up to date on workshop 11

Stay tuned...

The location will be announced soon.

RATE

Registration deadline for the full program by 1st of March 2024.


Prices are VAT excluded 

Full program (WS1 up to WS11) 

  • WSL' s Member :2400€
  • Non-member : 3600€


Single workshop
Registration 10 days before the date of the WS (see agenda) 

  • WSL' s Member : 350€/WS first attendee  –220€/WS second attendee of the same company. 
  • Non-member : 410€/WS first attendee  – 260€/WS second attendee of the same company. 

REGISTRATION

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