More than 30 medical device/combination product companies worldwide have been using TurboAC™ and/or GessNet consulting to address their needs in safety assurance cases, risk management, cybersecurity, product submissions, or regulatory compliance. FDA has the TurboAC™ software installed in its lab.
Dr. Andrei Yosef, VP of Q Core Medical in charge of product development, sharing their experience in using GessNet™ TurboAC™ risk management and safety assurance case software.
Q Core Medical has recently received FDA's clearance for its Shapphire infusion pump system (news release). The company has grown from 50 employees to more than 150 within less than two years. Play the video and listen to Dr. Andrei Yosef's comments on the TurboAC™ software.
Ross Gunton, Safety Assurance Case Engineer from Cellnovo: Cellnovo originally trialled a number of different Safety Assurance Case software packages but quickly discovered there was no single package that fulfilled all of our needs. Until we encountered the GessNet™ TurboAC™ software.
It became obvious very quickly that the GessNet™ TurboAC™ software provided a very thorough way of linking FMEA to Hazard Analysis with complete traceability – automatically! The automatic generation of Assurance Case Graphics and Fault Tree Analysis within the tool represents a huge performance plus when comparing GessNet™ TurboAC™ to other Safety Assurance Case software packages. Both time to market and project costs have been reduced simply as a result of this unique functionality. Since installing the GessNet™ TurboAC™ software, the training and customer support received from the team at GessNet™ has been of the highest levels. Online facilities, screen sharing and remote access tools are all available to assist us with any questions we may have whilst continuing our work on our Safety Assurance Case.
Peter Kollings, Director of RA/QA from EMED Technologies, Inc.: Until we came across TurboAC, our company could not find a suitable tool to develop safety assurance cases and bring our Risk Management processes to the next level. We found that the software ticked the right boxes, was obviously developed to align with real-world industry practices, and aligned well with our ISO 14971-compliant risk management system.
With the TurboAC software and GessNet’s expert support our small team was able to quickly import existing risk management information into a safety assurance case that met current regulatory expectations. It is not an overstatement in saying that the TurboAC software and GessNet’s experts were critical to the 510k clearance of our infusion pump system.
Thomas Bjurbo from Carticept Medical: Before we discovered TurboAC, the process of developing safety assurance cases for our infusion pump products was very time-intensive. With the more stringent assurance case requirements introduced in FDA’s final guidance for infusion pump 510(k) submissions, we began seeking a tool that would allow us to efficiently organize the increasing breadth of information that is necessary to support the safety case framework. The TurboAC software has met that need, and the readily-available support from GessNet has allowed us to quickly become proficient with the many features the tool provides. The GessNet team and their robust TurboAC software were without a doubt a key component to our most recent 510(k) clearance.
Daniel Bloomberg, Sr. System Engineer from Medtronic: I’ve been using TurboAC™ software for more than a year. It has been a great tool for our project. It offers creative solutions for overcoming many challenges facing risk management, and enables us to implement the industry best practices…
Roger Susi, President & CEO from Iradimed Corp: We've been using TurboAC™ software for developing and maintaining the safety assurance case for our MRI IV pump system. Obtaining and implementing the software turned out to be very timely and helpful as FDA recently expected use of safety assurance cases for infusion devices. TurboAC™ software has helped us to generate safety cases according to FDA guidance on infusion pumps and we plan to use it on all our development projects…
Eduardo Castro, Principal Quality Engineer from Philips Healthcare/Volcano: We were looking for a comprehensive solution to streamline and strengthen our risk management practices. When we learned about the capabilities of GessNet™ TurboAC™ software, we realized the software provides a practical roadmap for implementing best practices in the application of risk management to medical devices …
Andrei Yosef, VP of R&D from Q Core Medical Corp: For over 3 years, we've been using the TurboAC™ software for our Sapphire infusion pump system risk management and safety assurance case development and maintenance. We’ve used the software to develop safety assurance cases and obtained FDA clearance for multiple 510(k) submissions. We love the software: it enables us to generate safety assurance cases fully leveraging risk management information. It has also helped us establishing the best practices, and relieved our burden on time consuming and error-prone manual activities…
A System/Risk Management Engineer from one of our existing clients “.... We showed your TurboAC software to the FDA inspector. During the demo, the inspector was literally commenting 'I've never seen anyone doing anything like this before' ... No 483s indicated after an intensive inspection with 2 days focusing on risk management ... I am sure he was impressed from us and your software ... "
Risk management expert, co-author of ISO 14971 “Companies have been attempting to develop software solutions for medical device risk management for a while. Yours is making sense, neat, and I like it. I can see it will make it much easier to comply with EN ISO 14971:2012"
A user from FDA sharing its experience “… this software provides all the views and reports needed . I have not been aware of another software package capable to do all these...
System architect from a health care IT solutions company “Your software provides all I need for medical device risk managment. Not only for complying with ISO 14971, but also adopting good system engineering practices ...”
CEO of an infusion pump company "My team has been trying to develop the safety assurance case for our 510(k) submission to follow the FDA infusion pump guidance. We have tried many ways including researching different tools but none of the approaches seemed to make sense until we learned about your software - a new tool that allows us to leverage our existing risk management information. It makes practical sense. My team likes it...your software will become the industry standard once the industry learns about it."
Sr. quality/reliability manager from a large medical device company “Medical device risk management consumes a lot of resources, yet the output is poor and less usable since the work is done manually (e.g. tedious excel sheets) and by multiple functions in silos, lacking systematic view of how all the pieces are connected and tied together (e.g. FMEAs are not closely tied to hazard analysis). Product and post-production information are not connected to the pre-market risk management results (e.g. FTA, FMEA) and we might miss good opportunities to proactively manage potential product recalls and otherwise develop better next generation products. I can see that your software will greatly help to address these issues..."
PhD researcher from a University "Based on our research, your software is the only tool so far that can provide what I am looking for to develop a template to address medical device cybersecurity issues. We would either use yours or develop one of our own. We'd like to use yours ..."
Quality director of a major medical device company “I have seen your software in use during one of my supplier audits. I like it and would like to get it implemented for my own risk management program…”
Sr. staff reliability engineer of a large medical device company “The capability that your software can fully connect / integrate FMEA with Hazard Analysis or Fault Tree Analysis can solve one of our biggest challenges of risk management …”
MD from one of the top 5 hospitals in US “Your work is very "profound" and important …”; “…The safety assurance case graphic works great with Chrome web browser …beautiful work!”
VP of R&D from a medical device company “… I am looking forward to seeing your software succeed as you know I am a "true believer" in it. … I really love it.”
President of a startup medical device company “…We have evaluated other medical device system engineering and risk management software packages, and I have never seen a software package as comprehensive as yours. I am really impressed at its capability. This will be an excellent tool for what we need ...”
Director of QA/RA of an infusion pump company “…More we have used it, more impressed I have become with this software solution. The approach makes sense and I get it...”