62304 and FDA Compliance Training – June 4-6 in Boston

COURSE DATES: June 4 – 6, 2019
TRAINING LOCATION: Boston, MA USA

COST: 3 Full Days for $2,495.00
Limited number of “Early Bird” Discounted seats:  $1,795.00

Registration link

Only a limited number of discounted seats are available.  For more information on the course, use the form below.

This three-day course provides a clear understanding of the 62304 standard for medical device software, FDA expectations for software, and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment between them. In addition, participants will learn of other standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366). Special update includes SoftwareCPR recommendations for SaMD considering FDA Pre-Cert program!

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Key topics:

  • Amendment 1 changes to 62304 (changes to risk and dealing with legacy software)
  • Using Agile methods for medical device and HealthIT software – while remaining compliant!
  • Software risk management guidance from 80002-1
  • Using software safety classes to prioritize rigor and documentation
  • IEC 82304 for Health IT and standalone software
  • Cybersecurity planning, evaluation, and validation
  • IEC 62366-1 formative and summative usability/human factors for validation

Plus this bonus material:

  • Update on emerging standards impacting medical device and HealthIT software
  • Discussion on how privacy requirements (e.g., HIPAA) might intersect with risk management activities and cybersecurity procedures
  • Other relevant medical standards for networking safety
  • Workshops and exercises integrated throughout teaching modules

This 3 day course will be taught by John F. Murray, Jr., Alan Kusinitz, and Brian Pate of SoftwareCPR.

More information on SoftwareCPR courses at this link.

Full credentials on our website: www.softwarecpr.com

Who Should Attend?

Quality Assurance and Regulatory Affairs professionals. This course will provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management.
Product Owners, Scrum Masters/Coaches, software development managers/engineers, risk management, and test engineers. This course provides examples, checklists, and partial templates as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.

Training Location

Boston University – details forthcoming.

For more information

You can directly register at this link:  https://events.eventzilla.net/e/62304-and-emerging-software-standards-training-course-2138720953 or fill out this form for more info:

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

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