Does FDA accept regulatory submissions for medical devices and SaMD that have software developed using agile methods? What about IEC 62304 compliance? Can agile and lean approaches to software development be compliant? On February 18th and 19th, 2019, we will explore those topics and more at our 2019 “Being Agile & Compliant” public training course. ...Read More
COURSE DATES: February 18 – 19, 2019 TRAINING LOCATION: Tampa, Florida, USA COST: 2 Full Days for $2,495.00 January Registration Discount of 10% available through Jan 19, 2019. Extended to 1/25/2019. Ask about our multi-student discount as well! Meet our newest partner, John Murray, at the course! Download registration form Only a limited number of...Read More
A short, short time ago, in this very own galaxy some companies were not making blockbusters, but medical devices. Whispers of quicker development times and better testing made the way past the water cooler until it became time to indulge and implement the mythical software development lifecycle. With the changes came weird language and rumors...Read More
Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...Read More
The pdf at the link provided contains slides from a presentation by Brian Pate providing an overview of the soon to be released “Agile Methods for Medical Device Software Development” Technical Information Report (TIR). These slides focus on the TIR. We have posted another slide set in our library with some training slides on SoftwareCPR...Read More
The slides from a SoftwareCPR presentation on compliant use of Agile Methods for medical device software development is at the link provided. This was prepared and presented by Brian Pate and Mike Russell and similar slides are used in SoftwareCPR’s public courses. Agile For Medical Devices-SoftwareCPR PresentationRead More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.