10

Mar

2014

GessNet Risk Management and Safety Case Tool

14971, risk, tools

0

In SoftwareCPR’s opinion, a somewhat unique, very well conceived, and well designed tool for the specialized craft of risk analysis as well as safety assurance cases. The tool is very configurable, allowing customized structures for your own methods. The ability to view data from an FMEA, FTA, or table view saves valuable time during creation and reviews. This tool even generates safety cases from your data. Definitely the new state of the art tool for these tasks.

It allows tabular data entry and views rather than strictly graphical formats which can be cumbersome on their own. bIt provides some powerful ways to utilize existing risk analysis information and more easily generating safety cases. It was developed to focus on medical device risk management per IEC 14971 and safety case generation where requested by the U.S. FDA.

For more information about FDA and international standards compliant risk management and safety case development or help tailoring your risk management process using the GessNet Tool, leave us a message below and one of our experts will contact you.

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!

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

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

Lead Instructor: Mike Russell

Next public offerings:

Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025

Register using form at this link: Agile Course Post Promo

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