FDA issued a direct to final guidance on Cybersecurity for devices containing off-the-shelf (OTS) software and used on intranets or the internet. It is in question and answer format and states basic FDA expectations for the device manufacturer.
The FAQ at the link provided was subsequently issued to explain the purpose of this guidance to Healthcare Organizations.
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:
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
Call or email now to schedule a private, in-house class. The fall schedule is filling up!
Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.
Registration Link:
TBD
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
