By Steve Gompertz, QRx Partners When the FDA released the final Computer Software Assurance for Production and Quality System Software guidance, many in the industry expected only minor edits from the 2022 draft. They were wrong. The final version goes well beyond clarifying language. It reflects how dramatically manufacturing and quality systems have evolved, and how tightly FDA now aligns with ISO 13485 and modern digital infrastructure. A New World Under the QMSR How ofte

By: Steve Gompertz, QRx Partner It might sound like failure to say that I earned a degree in Mechanical Engineering and then never worked...

by: Steve Gompertz, QRx Partner I had an interesting discussion recently during a client audit on something I see often in CAPA...

By: Steve Gompertz, QRx Partner If you work in Medical Devices, you should already know that the FDA’s regulation 21 CFR Part 820 has...

By Steve Gompertz, QRx Partner As a consulting firm we get courted frequently by eQMS vendors who hope we will introduce our clients to...

By Mark Swanson, QRx Partner There has been some discussion around the amendment published in several of the ISO management system...

By: Mark Swanson, QRx Partner As we wind down in 2023, many people still hope that the final rule for the US Quality Management System...

By Steve Gompertz, QRx Partner I recently talked about this subject at the Masters Summit 2023 in Salt Lake City. For anyone who couldn't...

By: Mark Swanson, QRxPartner Planning to contact the FDA to get your product cleared?!? This process is often like looking through a...

by Steve Gompertz, QRx Partners We’re going in a different direction for this month’s blog article, by focusing on more of a “soft” skill...

Written by Mark Swanson, Partner On April 3rd, the FDA issued the draft guidance titled, “Marketing Submission Recommendations for a...

by Steve Gompertz, QRx Partners Performing audits is great way to increase your understanding of quality management system requirements...

by Mark Swanson and Steve Gompertz, QRx Partners While most medical devices are required to follow the 510(k) and PMA pathways, the FDA...

by Steve Gompertz, QRx Partners If you’re involved in the medical device industry, you’ve likely heard recently that the EU is...

By Mark Swanson, QRx Partners The latest ‘fad’ seems to be the push to apply artificial intelligence to medical devices and procedures....

by Steve Gompertz, QRx Partners While presenting workshops recently, the topic of training effectiveness kept coming up. In both...

Written By: Mark Swanson, Partner Last month (June 2022) saw the Medical Device Coordination Group (MDCG) issue a short (only 2 pages)...

Written By: Steve Gompertz, Partner It’s pretty common for Quality Manuals to depict the Quality Management System (QMS) structure as a...

Written By: Mark Swanson, Partner, CEO Having just returned from the MD&M West Conference in Anaheim, CA, it was interesting to hear what...

Written by: Steve Gompertz, Partner, COO During a presentation the other day on steps for effective Root Cause Analysis (RCA), attendees...