One of the most difficult challenges for medical device and HealthIT manufacturers is to properly "level" the design requirements for their medical device systems such that it is clear when it comes to design validation versus design verification.Read More
The FDA published a list of standards added to their recognition list on August 21, 2017. IEC 82304-1 Edition 1.0 2016-10. Health software part 1: General requirements for product safety are included on this list in the Software/Informatics Section, along with a number of other standards related to device communication (including specifics of glucose meters...Read More
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 content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR checklist for "IEC 82304-1: Health software - Part 1: General requirements for product safety." 82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device software as well...Read More
The new work item proposal (NWIP) for a standard for “Healthcare Software Systems – Part 1: General requirements” was approved in IEC. 82304-1 62A 839 CDRead More
Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification? We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing. Call us at 781-721-2921 or email firstname.lastname@example.org to start a conversation. We can provide estimates of cost and support your development tools.