When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun.  Often this is due to the nature of research itself – one is exploring a concept or design approach that may or may not pan out in the end.  The US...Read More

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."  Download: IEC 82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device...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