Catch up on the latest news from General Digital Software Services, including events, accomplishments, contracts, certifications and other noteworthy items of interest.
General Digital Corporation Granted ISO 9001:2015 Certification for its Quality Management System
South Windsor, CT (July 2, 2019) – General Digital Corporation (General Digital) today announced that the company has earned certification to ISO 9001:2015 for its Quality Management System.
General Digital is an engineering services company that:
- Designs and manufactures contemporary engineered solutions
- Specializes in designing and manufacturing industrial- and military-grade monitors, smart displays, computers, control electronics, systems integration and more
- Enhances performance of display systems through integration of overlays, surface coatings, optical film management, backlight redesign, and in-house optical bonding
- Provides safety-critical software development and testing services to aerospace, avionic, medical, transportation, industrial and other applications
The ISO 9001:2015 QMS certificate recognizes that General Digital’s quality management system is in conformance with the International Quality System Standard and was awarded by American Systems Registrar, an ANAB- and IATF -approved global registration services company.
On this award, Bryan Gudrian, president of General Digital said, “Achieving certification to ISO 9001:2015 QMS was a meticulous, company-wide process secured by third-party approval. This accomplishment highlights General Digital’s deep-rooted and unwavering commitment of excellence in providing our customers with the highest quality products and services across our three business units: Display Systems, Optical Bonding Laboratories, and Software Services.”
General Digital is committed to continuous improvement, constant focus on customer satisfaction, and advancing the efficiency of company processes to exceed customer and regulatory requirements. Achieving ISO 9001:2015 QMS certification demonstrates that General Digital quality processes and continuous improvement methodologies meet the highest industry standards.
About ISO 9001:2015 QMS
ISO 9001:2015 QMS obtained global recognition as the leading standard for Quality Management Systems (QMS) and can be implemented by companies regardless of their size and industry. Published by the International Organization for Standardization (ISO), the foundation of the ISO 9001:2015 QMS standard is grounded in effective quality management precepts. These precepts include increased focus on customer satisfaction, increased management, and the organization and advancement regarding the efficiency of processes. The recognition of and compliance with this certification culminates in the continuous improvement and production of products and services within an organization to exceed customer and regulatory requirements.
Software Services Develops Pupilometer Software with Partner AlgometRx
Scientists are looking for a way to measure pain, beyond the emoji-style sad faces.
This prototype was designed and built by General Digital engineers. The design specifications were form the inventor, Dr. Julia Finkel, a pediatric anesthesiologist and director of pain research at Children’s Sheikh Zayed Institute for Pediatric Surgical Innovation.
This is an important technology on so many levels. It is a game changer for the healthcare industry and will help pain management within healthcare institutes across the globe.
We are thrilled to be so much closer to bringing this extraordinary concept to life. Not only will it prove beneficial to the estimated 25 million people in the U.S. who experience daily pain*, as well as millions more worldwide, we anticipate it will help in the current opioid crisis by preventing patients asking for unnecessary prescriptions or doctors prescribing excessive dosages.
Read the article from AP News: https://bit.ly/2TMQgcX
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.
JULY & AUGUST 2014
Our Team is Growing
In July, our IV&V group welcomed new Test Engineer Alex Higgins.
In August, 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., from August 12–15. We look forward to meeting new faces and discussing software testing and any other topics of interest.