Medical Device Software: Complying with the MDR & FDA Regulations (London, United Kingdom - November 17-19, 2020) - ResearchAndMarkets.com

DUBLIN--()--The "Medical Device Software: Complying with the MDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering.

An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

This intensive three-day course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide. The programme will be highly interactive, using real-life examples and state-of-the-art practices identified by Notified Bodies in Europe. There will be in-depth coverage on how to prepare compliant technical file documentation for medical device software products and a review of software specification, risk management, architectures, usability and resulting design documentation. Presentations will also offer practical tips on how to streamline the development process and provide an understanding of the regulatory requirements and how Notified Bodies review technical files.

There will be sessions on the practical implication of risk management and usability and an analysis of the differences between FDA guidance and MDR guidance on medical device software. Software recalls, the use of apps in medical devices, the implications of the new draft usability standard, and advice on how to validate your system design will also be addressed.

Why you should attend

  • Learn how to qualify and classify software in Europe and the rest of the world
  • Get an in-depth understanding of the interpretations of MDR Classification Rules 10, 11, 12, 13, 15 and 22
  • Understand the implications of the MDR and US Code of Federal Regulations for software
  • Gain regulatory guidance on mobile apps, software as a service, cloud computing, artificial intelligence and continuous learning software
  • Learn how to write 510(k) and technical files
  • Get a practical understanding of quality management, design control and how it applies to agile software development
  • Hear the best practices on cybersecurity, risk management, usability and validation
  • Learn the principles of clinical evaluations for software as a medical device
  • Gain an insight into state-of-the-art standards applicable to software

Agenda:

Programme day one

Introduction to the regulations

Software qualification - is it a medical device or not?

  • Medical device definitions
  • In-vitro diagnostic software
  • Multi-functionality software
  • Cloud computing and software as a service
  • Intended purpose
  • Excluded functionality
  • Borderline with lifestyle and fitness software
  • Borderline with pharmaceuticals, combination products
  • Companion diagnostics, medication management and adherence apps
  • Population health and educational software
  • Resource and workflow management vs clinical decision support software
  • Clinical decision software

Considerations for placement on the market

  • International comparisons-qualification differences (US, Canada, Brazil,)
  • Pitfalls with the interpretation of the IMDRF SaMD risk framework
  • Pros and cons of the modular approach
  • software platforms
  • Software accessories, systems components

Case studies - qualification

Software classification

  • Implementing rules
  • Software that drives or influences the use of a (hardware) medical device
  • Classification rules, including classification rule 11
  • IMDRF SaMD risk type determination

Case studies - classification

MDR in a nutshell with software considerations

  • Go to market process
  • Engaging with a Notified Body
  • Controlling software suppliers and subcontractors
  • UDI number
  • EUDAMED
  • Declaration of Conformity
  • Person responsible for regulatory compliance
  • Software traceability
  • Distributors, importers, authorised representatives and their liability
  • App stores and digital distribution platforms
  • Software recalls
  • Unannounced Notified Body audits
  • Service updates, upgrades and other changes

Programme day two

Safety and performance requirements for software

  • Harmonised standards
  • Common specifications
  • GSPR checklist
  • Software labelling
  • Instructions for use

Practical construction of a technical file

  • Content
  • Example

Placing medical device software on the US market

  • US Code of Federal Regulations and its implications for software
  • 510(k) process
  • FDA guidance for software

Practical construction of a 510(k) International go-to-market considerations

  • Challenges faced for app developers to have their app taken up in care pathways
  • Quality and reliability of health and wellness apps
  • Evolving policy and reimbursement landscapes for digital health technologies
  • Quality and reliability of health and wellness apps

Controlled design of health software

  • Software development models
  • Design activities
  • Software development standards
  • Outsourcing

Software usability

  • Managing the human element of risk
  • Designing for happiness
  • Terminology, roles and responsibilities
  • Use Experience Design (USD)
  • Process and techniques
  • Formative evaluation
  • Summative evaluation
  • Regulatory requirements and standards

Programme day three

Clinical evaluations

  • Definitions, purpose, deliverables
  • Process and key characteristics
  • Methodology
  • Selecting data sources
  • The literature review process
  • Defining scope and a sufficient level of clinical evidence for medical device software
  • Role of validation and usability
  • Considerations for artificial intelligence and continuous learning software

Practical construction of a clinical evaluation plan and report

Development of a literature review protocol

Case studies - clinical evaluation of medical device software

Clinical investigations

  • General principles of clinical investigations
  • When is a clinical investigation needed for medical device software
  • Selecting an appropriate study design
  • Application of standards
  • Clinical performance studies
  • Generating evidence of effectiveness
  • Challenges of mHealth trials
  • Reporting
  • Regulatory and ethical considerations

Safety risk management - ISO 14971

  • Process, terminology, roles
  • Risk identification methodologies
  • Risk Control
  • Risk assessment and evaluation
  • Manufacturer accountability

Case studies - risk management

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 Post Market Clinical Follow-up for medical device software
  • Real-world evidence
  • Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working

Speakers:

Koen Cobbaert

Agfa HealthCare

QARA Manager

Zuzanna Kwade

Agfa Healthcare

For more information about this conference visit https://www.researchandmarkets.com/r/bibvwj

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900