HighRely Offers All-New FDA 510(k)/QSR Software Development & Compliance Training

2007-05-21, HighRely’s FDA 510(k)

Posted by admin 548 days ago (1)
Category: Financial

HighRely Incorporated has teamed with Green Hills software to offer HighRely’s previously private medical device software development strategies to the general public. Available in 1/2, 1, and 2-day formats, HighRely’s medical device software development training covers the FDA 510(k) process, FDA QSM compliance for software development, FDA 510(k) compliant software requirements, design, development, V&V, and software auditing for Class I, Class II, and Class III medical devices.

HighRely’s medical device 510(k) software trainers have trained over 6000 persons in safety-critical software development, processes, and compliance, including effective real-world strategies for FDA QSM 510(k) compliance. HighRely’s medical device 510k software training covers 510(k) software development compliance, FDA QSR compliance, leading medical device software development practices, medical device V&V, medical device software tools, and FDA 510(k) software whitepapers.

Says Mr. Mike Smith "HighRely’s new public training, launching on June 4 in San Jose, is a world-first: public training for real medical device engineers and managers by the company whose work is found in safety-critical devices world-wide and whose 100% U.S. based engineers are the most experienced in the safety-critical software business." Adds Mr. Tony Baghai, HighRely President "We’ve been helping medical device manufacturers improve their FDA 510k software development and FDA GMP software compliance for over 10 years. It’s a pleasure helping clients apply our success stories, as well as learn how to avoid the mistakes we’ve witnessed on dozens of programs. HighRely’s medical device software development training is the best available". Adds the manager of a San Diego based medical device manufacturer "The HighRely engineers really know how to communicate and deliver. They promise success, and they deliver it. They’re not the cheapest as we could always outsource to India. But HighRely speaks our "language" and is frankly the most cost-effective, even more cost-effective than the projects which we have outsourced to India. I highly recommend HighRely for embedded medical device software development services and 510(k) compliance via the FDA QSR."

Adds Reza Madjidi, a HighRely co-founder and leader of its medical device engineering services "HighRely’s new FDA 510(k) whitepapers on QSM Software Development and FDA 510k Software Development have been very popular and are available free at highrely.com/whitepapers.php.