This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Created a job aide which compares the IEC 62304 and IEC 82304 elements for requirements. This is only intended to be used as a starting point and requires interpretation based on knowledge of each standard and the type of...Read More
This SoftwareCPR.com newsletter in pdf form lists items added to the web site from mid Late December 2016 through late April. 2017. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists...Read More
The FDA page on Medical Device Use of Symbols in Labeling is at the link provided. FDA currently allows use of symbols in place of text for medical devices and certain biologics provided the use is compliant with 21 CFR Parts 660, 801, and 809. FDA Use of Symbols in Medical Device LabelingRead More
At the AAMI/FDA Software Regulatory Class being held this week, it was stated that the following are expected to be released this summer by FDA: – Revision to the premarket cybersecurity guidance – Final of the interoperability guidanceRead 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.
Leave a message and we will contact you to schedule: