2nd Annual Software Design for Medical Devices Europe schedule

Unscheduled

• CASE STUDY: Agile Methodology in a Complex Software Design and Integration for Improved Device Functionality

  • Continuous requirement change management along the 62304 lifecycle
  • Debating long process lifecycle vs. marketing study requirement evolution
  • Discussing the importance of Clinical Study during the Software lifecycle (earlier patient feedback and design tuning)
  • Parallelizing development and V&V to scrub and rework SW architecture and design efficiently

• Case Study: Agile Scrum Methodology Implementation within a Generation-Based Software Development Life Cycle

  - Giving an introduction to Given Imaging„s software development, validation and verification methodology
  - “Why Agile” – the need for a change!”
  - Adapting the Agile methodology into an existing process
  - Effectively executing the Agile processes
  “Post mortem” – learning from things that worked right and those that didn't …

• Case Study: An Outside Perspective – Developing Efficient Usability Processes at Novo Nordisk

  • Avoiding re-inventing the wheel: identifying the issues with your development process
  • Implementing a formal usability process to
  • Identifying and managing the “true” gaps in your knowledge
  • Lessons learned – efficiency, raising awareness and problem solving

• Case Study: From Concept to Completion: Developing Effective Usability Processes Across the Whole Product Lifecycle

  • “Generative sessions”: Talking to customers pre-concept stage in order to identify their needs and how they can be supported
  • Translating the customer's needs into solid ideas and usability models
  • Gaining feedback on those ideas via a range of different loops in order to improve the product
  • Ensuring compliance to ISO standards throughout your usability processes

• CASE STUDY: Implementation of Risk Management for the Whole Life Cycle of Medical Devices

  • Defining roles, responsibilities and activities in the whole Product Risk Management Process
  • Carefully documenting Risk Management Activities
  • Collecting and validating hazards: techniques and best practices
  • Effective handling of production and post-production information

• Case Study: Understanding the Changes within IEC 60601 3rd Edition and Developing an Efficient Compliance and Implementation Str

  • Reviewing the 2010 amendments to the directive
  • Discussing best practices for integrating these new requirements into product development
  • Understanding the realistic impact on both your business and your engineers
  • Assessing the expectations of regulators and notified bodies in terms of new submissions

• Designing Usable and Safe Medical Devices

  • Analysing and designing usability scenarios at the initial stages
  • Specifying the usability elements
  • Testing the device's safety and compliance
  • Creating, using and responding to a feedback loop from adverse effects

• INTERACTIVE SESSION: Insight Session: Overview of International Standards Activities Related to Medical Software Development

  This interactive discussion session outlines several global software standards activities with regard to medical software development. Patty, standards advisor for Medtronic, as well as leader of the teams working on the revision of IEC 62304 and the creation of IEC 82304 Healthcare Software Systems, will lead the discussion via video link.

  Topics will include:

  • Update on the revision of IEC 62304 Medical device software - software life cycle processes: information on the main areas of change
  • Update on the new work item IEC 82304 Healthcare software systems - background on what is driving this new work item
  • Information on the development of a guidance document on the use of agile practices in the development of medical device software

• INTERACTIVE SESSION: Panel Discussion: Standards for Software in Medical Devices: Updates, Compliance and Differences in Interpr

  • Recognising the various standards currently being used around the world
  • Discussing the different interpretations of 62304 and what Notified Bodies expect
  • Understanding how to structure your processes to ensure compliance
  • Analysing and overcoming the differences between the current standards and the upcoming 60601 3rd edition

• INTERACTIVE SESSION: Panel Discussion: Usability in Medical Device Design: Can we Improve Product Quality while Optimising Devel

  • Understanding the realistic time constraints in the software development life cycle
  • Mapping usability elements to your development processes to maximise efficiency
  • Debating the current stage of adoption and integration manufacturers are at with usability
  • Discussing the potential rewards and best practices for incorporating usability into design

• Legal and Regulatory Aspects of Medical Devices Software: Do's, Don'ts and Developments

  • Giving an overview of EU legal and regulatory requirements for medical devices software
  • Understanding how to decide if software is regulated as medical device
  • Special focus on applications on mobile platforms and websites
  • Managing subcontracted software development effectively

• REGULATOR: Afternoon Keynote: The FDA Perspective on Human Factors in Medical Device Software Development

  • Discussing the FDA draft guidelines and current perspective on human factors in software development
  • Establishing human factors best practices
  • Evaluating how human factors relate to research and development activities
  • Fulfilling regulatory requirements and guidance

• REGULATOR: Comprehending and Complying to the New EU Guideline on the Qualification and Classification of Standalone Software in

  • Defining both “software” and the changes in the guideline
  • Demonstrating the new qualification criteria and decision trees
  • Discussing general health care IT systems at the borderline of medical device software
  • Learning from examples and frequently asked questions

• Risk Management: Using Human Factors Engineering to Manage the Risk of Use Error in Medical Software

  • Understanding the Human Factors Engineering process and its methodology
  • Applying it within software design for medical products
  • Discussing the regulations, standards and best practices regarding HFE
  • A case study example of effective use of HFE in medical software development

• The Shifting Landscape of Software Compliance

  • History of regulatory concern with software
  • Recent expansions of software related guidance and regulations
  • Changes in international standards for lifecycle, risk management, and device safety
  • Impact of new software-fueled technologies on traditional regulatory structure