Tijdens deze opleiding krijgt u een goed begrip van de Europese verordening inzake medische hulpmiddelen. Of uw software nu een app is of een cloud computing service, of het nu gaat om firmware voor integratie in een medisch apparaat, om kunstmatige intelligentie of om een IoT-toepassing, deze opleiding verdiept uw kennis over hoe de regelgeving uw product beïnvloedt.


Aan de hand van scene-setting introducties en ervaringen uit de praktijk worden tijdens deze tweedaagse Academy-opleiding de praktische implicaties van de Europese verordening inzake medische hulpmiddelen duidelijk. U leert welke eisen voor u relevant zijn en hoe u de meest optimale route kunt kiezen om uw software onder de nieuwe regelgeving voor medische hulpmiddelen op de markt te brengen.

De opleiding vindt plaats in BluePoint Brussels en wordt in het Engels gedoceerd. U kunt ofwel enkel de eerste lesdag volgen, ofwel de volledige cyclus van twee lesdagen.


Programma

Dag 1 (donderdag 6 juni 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

13.45

Bringing medical device software to 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 - Networking Cocktail

18.00

End

 

Dag 2 (donderdag 13 juni 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
10.30 Break
10.45 Cyber security 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
15.00 Break
15.15 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

Datum

donderdag 6 juni 2019, 09:00 - 18:00

donderdag 13 juni 2019, 09:00 - 17:00

Plaats

BluePoint Brussels
A. Reyerslaan 80
1030 Brussel

Organisator

Agoria 

Meer info

- Agoria-leden: € 660/2 dagen of € 330/1 dag
- IHE Belgium leden: € 990/2 dagen of € 495/1 dag (meer info over lidmaatschap bij Karlien Erauw)
- Niet-leden: € 1320/2 dagen of € 660/1 dag
- Lunch, koffiepauzes & lesmateriaal inbegrepen

Agoria is erkend als dienstverlener in het kader van de Vlaamse KMO-portefeuille. Dat betekent dat wanneer u als Vlaamse kmo bij ons een betalende opleiding van min. 100 euro (excl. BTW) volgt, de Vlaamse overheid een deel van de kostprijs subsidieert. Ons erkenningsnummer is DV.O205861. Opgelet: Agoria leden kunnen enkel een beroep doen op de KMO-portefeuille als zij toegetreden lid zijn. Meer uitleg vindt u hier.

Op deze opleiding zijn de algemene voorwaarden van toepassing die gelden binnen Agoria VZW.
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