Cette formation vous permettra de bien comprendre la réglementation européenne sur les dispositifs médicaux. Qu'il s'agisse d'une application ou d'un service de cloud computing, qu'il s'agisse d'un firmware à intégrer dans un dispositif médical, d'intelligence artificielle ou d'une application IoT, cette formation vous permettra d'approfondir vos connaissances sur les effets de la réglementation sur votre produit.


Au travers d'introductions et d'expériences pratiques, les implications pratiques de la réglementation européenne sur les dispositifs médicaux deviennent claires au cours de cette formation Agoria Academy de deux jours . Vous apprendrez quelles sont les exigences qui vous concernent et comment choisir la meilleure voie pour mettre votre logiciel sur le marché en conformité avec le nouveau règlement sur les instruments médicaux.

Cette formation se déroulera à BluePoint Brussels et sera donnée en anglais. Vous pouvez suivre uniquement le premier jour, ou bien la formation complète de deux jours.

Programme jour 1 (jeudi 6 juin 2019)

9.00     Introduction to the Regulations 

9.30     Medical device qualification

  • Medical device definitions
  • Annex XVI products
  • Multi-functionality software
  • Cloud computing and software as a service
  • Intended purpose
  • Excluded functionality
  • Borderline with lifestyle and fitness software
  • Population health and educational software
  • Resource and workflow management vs clinical decision support software
  • Clinical decision software
  • Quiz

10.45   Coffee break

11.00 Medical device classification (focus on software)

  • Implementing Rules
  • Software that drives or influences the use of a (hardware) medical device
  • Classification Rules
  • IMDRF SaMD risk type determination
  • Case studies
  • Quiz

 12.15 Lunch

 13h15 Bringing medical device software on the EU Market legally

  • Go to market process
  • Engaging with a Notified Body
  • Implementing a Quality Management System (ISO 13485)
  • Controlling your suppliers and subcontractors
  • UDI number
  • EUDAMED
  • Declaration of Conformity
  • Person Responsible for Regulatory Compliance

 14.00 Keeping your medical device on the market legally

  • Assuring the traceability of your product
  • Distributors, importers, authorized representatives and their liability
  • App Stores and Digital Distribution Platforms              
  • Complaint handling system
  • Medical Incident Reporting
  • Monitoring critical components or platforms updates
  • Post market surveillance requirements
  • Unannounced Notified Body Audits
  • Service updates, upgrades and other changes
  • Quiz

 14.30 Coffee Break

 14.45 General Safety and Performance Requirements (GSPR)

  • Harmonised standards
  • Common specifications
  • GSPR Checklist
  • Interpretation of GSPR and their implications for software
    • Reduce risk as far as possible
    • State of the art
    • Single fault condition
    • IT environment and mobile platforms
    • Diagnostic and measuring function
    • Repeatability and reliability (e.g. of machine learning)
    • Lifetime of a device
    • Information on the manufacturers website
    • Instructions for use
    • Label

 16.00 Practical Construction of a Technical file

 16.30 Lessons learned – practical case

 17.00   Q&A during networking cocktail

18.00   End

 Programme jour 2 (jeudi 13 juin 2019)

9.00     Safety Risk Management – ISO 14971

  • Process, terminology, roles
  • Risk Identification Methodologies
    • Checklists
    • Grey Box
    • Hazard and Operability Analysis (HAZOP)
    • Failure Mode and Effects Analysis (FMEA)
    • Fault Tree Analysis (FTE)
  • Risk Control
    • Inherently safe design
    • Preventive measures
    • Corrective measures
    • Mitigations
    • Safety notices
    • Disclosures of residual risk
    • Risk control strategies
  • Risk assessment & evaluation
    • IMDRF terminology
    • Determining severity and probability of harm
    • Determining if a risk is acceptable
    • Benefit-risk assessment
    • Deliverables
  • Manufacturer accountability
    • Risk management throughout the product lifecycle
    • Normal, abnormal and misuse
    • ESCs, SOUPs and COTS
    • Platform changes and failures
    • Quiz

 10.30 Break

 10.45 Cybersecurity risk management

  • Assuring information integrity, security and privacy (ISO/IEC 27001)
  • Practical design of secure software
  • Security Risk Management
  • Process maturity
  • Security awareness
  • Penetration testing
  • Manufacturer Disclosure Statements
  • Patching strategy
  • Secure Disposal and Reuse
  • Assuring the security of products that contain third party components
  • Balancing safety with security
  • Applicable information integrity security and privacy legislation

 11.45 Controlled design of health software

  • Software Life Cycle Process (IEC 62304, IEC 82304)
  • Software Development Requirements & Design Controls
  • Agile software development
  • Management of software suppliers
  • Use of open source software
  • Software platforms and plugins
  • Legacy software
  • Project management, development planning & change management
  • Requirements management
  • Software architecture & design
  • Development
  • Configuration management
  • Software verification and validation

 12.30 Lunch

 13.30 Clinical Evaluations of medical device software

  • Definitions, purpose, deliverables
  • Process & key characteristics
  • Methodology
  • Role of validation and usability (IEC 62366 Usability of medical devices)
  • Use of real-world evidence
  • Process interface with risk management, validation, usability engineering and post-market surveillance
  • Practical construction of a clinical evaluation report (template, case study)
  • Clinical evaluations of machine learning software

15h00 Break

15h15 Post Market Surveillance

  • Post-market regulatory requirements
  • Components of an effective PMS
  • Process interface with CAPA, NC, vigilance, service, periodic safety updates, trend reporting
  • Implementation of PMS
  • Post-Market Clinical Follow-up
  • Best practices

15.45 Considerations for designing and running clinical trials with medical device software

  • When is a clinical investigation needed for medical device software
  • ISO 14155: Roles & responsibilities
  • Selecting appropriate study design
  • Regulatory and ethical considerations
  • Diagnostic Clinical Performance Studies
  • Sustaining the Quality of Clinical Studies
  • Handling clinical data
  • Analysis and reporting

16.45  Q&A

17.00 End

Date

jeudi 6 juin 2019, 09:00 - 18:00

jeudi 13 juin 2019, 09:00 - 17:00

Lieu

BluePoint Brussels
Bd A. Reyers 80
1030 Bruxelles

Plan d'accès

Organisateur

Agoria 

Plus d'info

- membres Agoria: € 660/2 jours ou € 330/1 jour
- membres IHE Belgium : € 990/2 jours of € 495/1 jours (plus d'info sur IHE Belgium: contactez Karlien Erauw)
- non-membres: € 1320/2 jours of € 660/1 jour
- Lunch, pauses-café & matériel didactique inclus

Les conditions générales d'Agoria ASBL sont applicables à cette formation.
Inscrivez-vous