FDA’s biologic division sponsored the second video conference on 21 CFR 11 Electronic Records;electronic signatures on October 21, 1999. Speakers included Paul Motise, Christine Nelson and other FDA experts on this rule. FDA made available a videotape of this conference. Click on the link provided for ordering information direct from their provider. Subscribers to SoftwareCPR.com and consulting clients of SoftwareCPR may request a free loaner copy of the tape from our online store.
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: TBD
Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.
Registration Link:
TBD
Being Agile & Yet Compliant (Public or Private)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!
2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.
Instructors: Mike Russell, Ron Baerg
Next public offering: March 7 & 28, 2024
Virtual via Zoom
Registration Link:
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
