Sep

2022

Hurricane Ian – Possible Disruptions

(Tampa, FL, September 28, 2022) – Crisis Prevention and Recovery, LLC is taking proactive steps to minimize impact to our clients from the landfall of Hurricane Ian in Southwest Florida. With our corporate office in Tampa, Florida, it is likely that there could be loss of electrical power and/or internet in the next 24 to 72 hours. We believe that in any case, we should be fully operational by Monday morning, October 3, 2022.

We do not expect impact to our email service nor our website service.

If you have an urgent issue that must be addressed prior to Monday, October 3, 2022, our corporate office number should forward to mobile phone service. Please leave a message, or email mrussell@softwarecpr.com.

Our office number is +1-781-721-2921.

About the author

Brian Pate

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on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1).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.

PrevNext

Risk Management (Public or Private)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective training course is now open for scheduling!

Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
System level hazards analysis – mapping to software, cybersecurity, and usability
Why FMEA is incomplete for medical device risk management.
How to perform software hazards analysis.
And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Dr. Peter Rech, Brian Pate

Next public offering: 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!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: 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

IEC 62304 and other emerging standards for Medical Device and HealthIT Software (Public or Private)

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, 2nd instructor (optional)

Next public offering: TBD

Hurricane Ian – Possible Disruptions

Brian Pate

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