COURSE DATES: June 4 – 6, 2019 TRAINING LOCATION: Boston, MA USA COST: 3 Full Days for $2,495.00 Limited number of “Early Bird” Discounted seats: $1,795.00 Registration link Only a limited number of discounted seats are available. For more information on the course, use the form below. This three-day course provides a clear understanding of...Read More
What does one need to know about IEC 62304? In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience. The topics we plan to cover in our 2019 course are below. Topics: Regulatory...Read More
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
SoftwareCPR® – Human Factors and Usability Engineering Assessment Does the design of your device promote safe and effective use? Are you ready for an FDA regulatory submission requiring HFE/UE report? Do you maintain a usability engineering file for your products? Is it complete? Do you have a systematic process for identifying and analyzing use error?...Read More
How does one know what standards are helpful when creating or updating your software development process? Can compliance with standards benefit a medical device or HealthIT company with regulatory approval and/or FDA inspections? These questions and more will be answered at the upcoming 62304 training and emerging standards impacting Medical Device software and Health IT...Read More
Lucille Ferus a Partner at SoftwareCPR provided training to the Tawian FDA on US and international medical device software regulation in April. We continue to see increased focus on software regulation in countries outside the US..Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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