You will learn how to:
- View from an agile perspective and adapt the key international standard IEC 62304 Medical device software — Software life cycle processes, along with an introduction to aspects from other key standards like ISO 14971 Application of risk management to medical devices.
- Leverage agile principles of being iterative and incremental to your advantage.
- Reduce workloads and increase device confidence by avoiding the common “one size fits all” risk management approach.
Course modules provide an overview of the regulatory and agile contexts, then examine the effective blending of agility and compliance at iteration, release, and product levels. Modules include concepts, techniques, examples, and Q&A.
As with all SoftwareCPR® courses, our approach is to focus first on the intent, purpose, and principles, not just “checklists,” so participants can make informed decisions about their unique situations. Our training is profitable for all roles in medical device software development, including managers and regulatory and quality specialists … not just developers.
Register now, as we limit the number of participants in our virtual courses to provide discussion opportunities for all.