Promise your product will do what it promises.
Before they can be legally distributed in the United States, safety-critical products require certification, (e.g., FDA, FAA, etc.). Part of this certification effort is validating that the product will do what it is supposed to do and is safe for use—particularly for applications involving software.
With over 35 years of experience in highly-regulated industries, our team of software development experts knows compliance rules and regulations—and how to meet and exceed them. What’s more, we’ve developed internal tools and processes that enable us to get your product through a certification effort 100% of the time.
Over 30 years ago, in the early days of safety-critical software testing, we partnered with Hamilton Standard to provide Independent Verification & Validation (IV&V) services for FAA authorizations. At that time, there were no standardized industry best-practices, and FAA product submissions were notoriously delayed as regulators struggled to interpret a variety of test reports. We recognized the need for process improvements, and developed methods to clearly outline requirement coverage in test reports that was well received by regulators—with some of our insights even being incorporated into future iterations of DO-178.
While we found an early niche in aviation, as technology advanced, so too did regulations surrounding medical devices and transportation. Drawing from our rich history of avionic software testing, we were able to develop internal tools to streamline processes and quickly adapt to the needs of new industries.
- Requirements Development and Analysis
- Product Design
- Software Coding
- Software Testing (IV&V)
- Regulatory Submission
- Product Deployment
- Product Maintenance
Our Compliance Standards
RTCA DO-178, DO-326, DO-254; IAQG AS9100
IEC 62304; ISO 13485; CFR 820.30; CE/MDR
FDA 510(k) Premarket Notifications
IEC 61508, 61131
IEC 62279, 61508; ISO 26262
Get Certified—Before Your Competitors Do.
We can help in any stage of product submission to regulators, from requirements definition to IV&V testing to final submission. However, time is always of the essence when it comes to developing a regulatory plan—and the sooner you start in the process, the better.
When you follow the rules from the start and design your product to comply, you’ll be avoiding costly recalls and potential litigation, saving millions of dollars in reworking and reverse-engineering processes.
Trusted by the world’s most respected companies.
|Airbus||Electric Boat||Otis Elevator|
|Ford Motor Company||Pratt & Whitney||Collins Aerospace (formerly UTC Aerospace)|
|General Motors Corporation||Rolls-Royce||Draper Laboratories|
|Gerber Scientific||Sikorsky||Triumph Engine Control Systems|