The European Commission has issued a final guidance on standalone software entitled: “GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES.” Updated in 2015.Read More
For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive...Read More
The Institute of Medicine report is at the link provided. Health IT and Patient Safety ReportRead More
Need Your Input!
We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course? What are the least favored (not workable) months?
