December 2022 SoftwareCPR Agile and Compliant Training Course

Monday, 12 December 2022 11:00 AM - Thursday, 15 December 2022 3:00 PM EST

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BF2022-Special Partial Approval - $1,500.00

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Full Registration Partial Approval - $1,920.00

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Early Bird Registration Partial Approval - $1,700.00

Early bird registration only available through September 30, 2022. Non-refundable, but substitutions allowed. Number of tickets is limited.

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Monday, 12 December 2022 11:00 AM - Thursday, 15 December 2022 3:00 PM EST

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.

Crisis Prevention and Recovery LLC (SoftwareCPR)

Crisis Prevention and Recovery LLC does business as SoftwareCPR®. SoftwareCPR® consists of several partners who are experts in FDA regulation (and ISO standards) in general, and medical device software in particular. Most of our partners and affiliates are former practitioners – they were in the trenches at one time developing and/or qualifying medical devices and the software associated with those products. Our experience ranges from deeply embedded software to SaMD running on standard platforms, from complex control algorithms to user interface graphical software, and from the test lab to the executive board room. We have many years of experience – most of our partners have been in this industry for over 30 years! Well seasoned we like to say. We can get to the core issues quickly and save you time and money. We do not use a one-size-fits-all approach – we seek first to understand our clients’ culture, what makes their products unique, and how quality assurance already exists in their DNA. Our support can range from strategic advice on regulatory classification to full hands-on remediation of any quality system documentation or records. We even can provide many types of design verification and usability evaluations.

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