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 is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

PrevNext

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 5-7, 2024
Boston, MA

Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.

Registration Link:

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 (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

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

Hurricane Ian – Possible Disruptions

Brian Pate

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