News and Announcements

Slides and a recording of the July 14, 2021 Dallas/Fort Worth Discussion Group webinar Simple, Quick, Practical Alternative to Performing Gage R&R and Specification Guardbanding presented by John Zorich are available under the Files tab on the MyASQ Medical Device Division Community page. They can be accessed by clinking the link below. ... more
Dear segment leaders with manufacturing oriented members; Thanks for announcing the Leading Indicators research and survey webinar this evening to your membership. We have had a request for a second presentation of the topic on April 6 th . Please share this announcement with your membership. We are hoping to get a critical mass of survey volunteers ... more
Part I on Auditing contains new content on Data Privacy, Data Integrity Principles, and the Medical Device Single Audit Program (MDSAP). Part II on Medical Device Quality Management System Requirements contains an entirely new Chapter 6, as the subject of “The EU Medical Device Regulation” has replaced “The EU Medical Device Directives.” Chapters ... more
Breaking IVDR/MDR News - today the European Commission published an information Notice to confirm that Notified Bodies may temporarily deviate, in extraordinary and individual cases, from the IVDR/MDR requirement for audits of manufacturers’ quality management systems (QMS) to take place ‘on site.’ This is a significant and positive ... more
Hidden in the recently approved COVD funding bill is additional funding for FDA. The FDA received $55m on the battle against COVID 19 (including $1.5m to monitor medical supply chains and funding on reforms for OTC drugs). There is also an increase of $42m to fiscal FDA funding. Hidden in the $42m are some interesting line items, like $7m for artificial ... more