IEC 62304 and Emerging Standards for Medical Device and Health IT Software
DATES: Sep 21-23, 2021 (completed)
Clock time each day: 8:30 am – 4:30 pm US (timezone TBD)
COST: 3 Full Days for $2,100.00 (Early Bird discount: $1595 thru August 1, 2021)
Multi-student discounts available.
Refunds (minus credit card fees) through August 1, 2021. However, substitutions are allowed up until the day before the course starts.
This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software, including FDA expectations for software and alignment with 62304, and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment between them. In addition, participants will learn 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).
- Applying risk management to software including guidance from 80002-1
- 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!
- 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 Brian Pate of SoftwareCPR using Zoom virtual meeting (or similar virtual method).
Course Flyer: 2021 SoftwareCPR 62304 Course-One Page Flyer-Virtual-r1
Looking for Quality System Software (CSV, production/manufacturing, tools, etc.) Training? See our other SoftwareCPR courses at this https://www.softwarecpr.com/training/.
Full credentials on our website: www.softwarecpr.com
Who Should Attend this 62304 Public Training Course?
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.