FDA issued a draft guidance for Drugs and Biologics titled: Data Integrity and Compliance With CGMP. While s number of the concepts are conceptually relevant to device manufacturers one must be careful with interpretation since the requirements in this guidance are specifically related to elements of the Drug CGMPs and these are not identical to the requirements of Device CGMPs in 21 CFR 820 and related regualtions.
IEC 62304 and other emerging standards for Medical Device and HealthIT Software
Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.
3-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Brian Pate
Next public offering: June 24-26, 2025 (Boston, MA)
Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person. These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.
For private, in-house courses, please contact us.
Email training@softwarecpr.com for more info.
Being Agile & Yet Compliant (Public)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!
3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
Lead Instructor: Mike Russell
Next public offerings:
Medical Device Cybersecurity (Public or Private)
This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.
2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
