Catch up on the latest news from General Digital Software Services, including events, accomplishments, contracts, certifications and other noteworthy items of interest.
The EU Clamps Down on Medical Device Regulations
At this moment in the global economy, one of the most talked about subjects is the Trump administration’s tariffs around the globe. Disregarding the political chatter, their stated objective is to create fair-trade agreements, by way of tariffs, between the USA and our import/export leaders: China and the European Union (EU).
Recently, the Trump administration and the EU have come to an agreement in these ongoing negotiations. This agreement includes, in part, the regulation of medical devices. As specifics of the regulation are not within the scope of this article, the bottom line is that, historically, medical devices had far fewer hurdles to overcome in the EU. The much sought after CE mark was much more easily attained than FDA approval, meaning devices were more readily marketed in the EU than the USA.
Some products would be fast-tracked to market by going to Europe or elsewhere first. This route yielded two notable results:
- The US population was losing out on technology and treatments because of a substantial increase in the time it took for medical devices to get to market.
- The EU lost out on safety and quality, though as of May 2020, that situation will be reversed. This is all due to the fact that medical devices in Europe will have to go through a similar process to that of FDA approval in the US. In the EU, it will most likely fall under, or be added to, Medical Device Regulation 2017/745. This means that medical devices once unavailable to the US because of pre-approval regulations must now undergo regulations that will be monitored and checked before the devices can come to market.
For any new devices coming to market, or legacy devices requiring this new approval, General Digital Software Services is one of the few companies worldwide that can help. Our 45+ years of expertise in safety-critical software development, IV&V testing and documentation has prepared us to assist any organization seeking FDA approval for medical devices. We provide the most efficient and cost-effective means to get the safest, highest quality medical devices to market.
We Welcome a New Intern
General Digital welcomes Melissa Levin to an internship in our Marketing Department. She is in her senior year at the University of Connecticut, studying communications with hopes of pursing a career in marketing and public relations.
Since she started, she has worked on numerous projects including producing social media content each week, assisting in Web site revision, analyzing competitors, and assisting in growing business relations. In her free time, she loves to listen to podcasts, try new restaurants, and spend time at the beach!
IV&V Department is Breaking Records
Recently, General Digital’s Software Services group has taken on quite a few new hires to help with the latest contracts we acquired, serving the industrial and medical fields. In April, with the big boost of personnel behind these projects, we surpassed our previous monthly record of 2,000 hours from our dedicated and diligent Independent Verification and Validation team!
This is an exciting time for us, as our company is growing not only in size, but in capability and expertise within these fields. With the benefit of our decades of experience performing saftey-critical IV&V testing in the military and aerospace industries, we are well equipped to assist our medical industry customers gain FDA approval for their new medical devices.
What we have learned from this accomplishment is that General Digital can provide IV&V services for startup companies in record time compared to that of most competitors. Of course, it’s not only speed that matters, but precision as well, which is especially important when testing safety-critical products and systems.
Kicking Off the New Year with New Software Contracts
General Digital is happy to announce that the new year has brought forth quite a few new software opportunities in the aerospace industry. One project integrates hardware and software for a specialized weatherproofing application to be used in the field. Other projects include local aerospace manufacturers who are utilizing our expertise and consulting services to create high quality software that will enhance their internal software processing systems. Additionally, we will continue our ongoing partnerships with aerospace manufacturers and developers to enhance and test their software.
In current projects, after many trial and error sessions, General Digital is proud to announce that the first working prototypes for our partnered startup medical device company have been delivered for ongoing testing. We look forward to the next phase of this exciting new and innovative product, as well as helping them with FDA submissions and further enhancing their product lines.
Whether a customer is developing a new product or software, or attempting to retrofit/recertify a legacy system, General Digital’s experienced staff provides the independent assessments an organization needs to meet high quality software requirements. We are always at the ready to help our customers meet the ever-changing and demanding requirements of most industries, such as medical, avionics, transportation or industrial.
General Digital Welcomes Many New Hires
General Digital has just expanded our Software Services business unit with new hires. The department has nearly doubled in size over the past few months, as we have been awarded several new contracts for software development and IV&V testing. We want to thank Software Services Sales & Business Manager Bill Stamm and everyone else for all of their work in expanding and further strengthening this business unit.
General Digital Wins Contracts from Multiple Medical Device Companies
Our recently won contracts from multiple medical device companies (from startups to billion dollar global companies) have more than helped us prove ourselves as experts in the field. As well, they have readied us for the potential troubles experienced by many startup medical device companies, such as finalizing their products to become FDA (Food & Drug Administration) certified and pass SEA (Software Engineering & Applications) regulations.
Recently, the medical industry has implemented changes intended to more strictly regulate itself. Specifically, the SEA has incorporated many aspects of DO-178 into its new requirements, and is demanding greater traceability and independence for FDA approval and certification.
For over 25 years, General Digital’s Software Services Group has supplied IV&V (Independent Verification and Validation) services to the aerospace industry in compliance with DO-178 standards for safety-critical software. Our unrivaled experience performing manual and automated testing of life and mission-critical systems, as well as the qualification of the toolsets used to perform testing, has made General Digital a leader in the software testing field. This intimate knowledge of DO-178 requirements will allow us to seamlessly apply our unique talents to the medical market, and position ourselves as the subject matter experts to provide consultative services and testing. We are uniquely qualified to help our customers better understand the certification requirements, as well as perform IV&V services and provide software development.
Whether our customer is developing a new product, or attempting to retrofit/recertify a legacy solution, General Digital’s experienced staff provides the independent assessments necessary to obtain complete and accurate high quality software requirements, as well as help its customers meet the ever changing and more demanding requirements of the medical marketplace.
Development and Verification Completed
General Digital Software Services recently completed a development and verification effort for a sub-component of the CH-47 Chinook helicopter.
Our Team is Growing
Our Software Engineering group welcomes a new Software Engineer, Bill Crabtree. Bill was previously employed with General Digital many years ago.
KC-390 First Flight Successful!
General Digital Software Services is extremely proud that we were an integral part of the verification efforts for the KC-390. Way to go, team! Great job!
Read the press release from Embraer SA: https://lnkd.in/dP2fufv
Medical & Avionics Software Testing Blog Release
Read our latest blog post discussing how medical device and avionics software testing are very similar processes.
MFD Project Going Well
The Software Engineering group is making good progress on the prototype of the Multifunction Cockpit Display project that is targeted for rotary-wing and fixed-wing aircraft (and we are considering derivatives for other industries).
While the General Digital Graphics Processing Unit (GPU) and Aircraft Communications FPGAs are in development, the software group is writing the planning documents, developing the graphic elements and real-time animations, and evaluating Real-Time Operating Systems.
Our Team is Growing
Our IV&V group welcomes new Test Engineer Alex Higgins.
Our Software Engineering group welcomes new Software Engineers Dan Guerrera from UCONN School of Engineering, and Laura Eberhard from XOS Corporation. For their first task, Dan and Laura will be developing software for a Multifunction Cockpit Display Project.
Software Services will have a booth at AUVSI’s Unmanned Systems 2013 trade show in Washington, D.C. We look forward to meeting new faces and discussing software testing and any other topics of interest.