2-Day Course: Medical Device Software - Complying with the 2018 MDR & FDA Regulations (London, United Kingdom - April 29-30, 2019) - ResearchAndMarkets.com

The "Medical Device Software: Complying with the MDR & FDA Regulations 2018" conference has been added to ResearchAndMarkets.com's offering.

This course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide.

The seminar 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. In addition, there will be practical tips on how to streamline the development process, understand 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 covered.

Benefits of Attending

• Learn how to qualify and classify software in Europe and the rest of the world
• Get in-depth understanding of the interpretations of MDR Classification Rule 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 510K 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 cyber security, 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

Who Should Attend?

• Senior management and project leaders
• Software product managers, researchers, developers and clinical experts
• Software development process managers
• IT managers and integrators
• Internal and external auditors and/or consultants
• Regulatory affairs professionals
• Quality system and quality assurance personnel
• Technical and medical writers
• GUI designers

Agenda

Programme Day One

Medical device software qualification and classification

• MD and IVD definitions
• Annex XVI products
• In-vitro diagnostic software
• Multi-functionality software
• Cloud computing and software as a service
• Intended purpose
• Exempted functionality
• Borderline with lifestyle and fitness software
• Combination products - MD software to pharma
• Population health and educational software
• Drive or influence the use of a medical device
• Quiz

Software classification - EU

• Classification rules and the related definitions
• Helsinki procedure and the borderline manual on qualification and classification
• Implementing rules
• Classification rules for active devices
• Interpreting Rules 10, 11, 12, 13, 15 and 22
• Classification under the IVDR
• Case studies
• Quiz

Classification according to the FDA

Bringing medical device software on the EU market

• Go to market process MD and IVD
• Go to market process combination products
• In-house use by health institutions

Notified Bodies and the evidence they consider

• Engaging with a Notified Body
• Implementing a Quality Management System
• Standards to consider
• General safety and performance requirements
• Technical file and clinical evaluation assessment
• UDI number
• Translations
• Declaration of Conformity

Practical construction of a technical file

EUDAMED registration and distribution chain responsibilities

• EUDAMED
• Person responsible for regulatory compliance
• Assuring the traceability of your software
• Distributors, importers and authorised representatives
• Controlling your suppliers and subcontractors

On the market

• 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

Programme Day Two

Bringing medical software on the US market

• US Code of Federal Regulations and its implications for software
• Process and practical construction of a 510(K)
• A case study

Rest of the world (Brazil, Canada etc.)

Standards and their implementation - a software perspective

• ISO 14971 Risk management
• IEC 62304 and IEC 82304 Software lifecycle and safety
• IEC 60601 Electrical equipment
• IEC 62366 Usability of medical devices
• EN ISO 15223-1/ /ISO 15223 Symbols
• IEC 27000 etc. Security standards
• User manuals

Fundamental principles design control

Design activities in detail

• Project management, development planning and change management
• Requirements management
• Risk management
• Clinical evaluation
  • IMDRF on clinical evaluation
  • FDA expectations
  • PACS, mobile apps
  • Clinical decision support
  • Computer-aided detection and diagnosis
  • MEDDEV on clinical evaluation
• Architecture and design
• Development
• Configuration management
• Verification and validation
• Usability

For more information about this conference visit https://www.researchandmarkets.com/research/grlw5j/2day_course?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190222005314/en/