May 2019 Posts

EU MDR: T-Minus 371 Days…Are You Equipped?

EU MDR: T-Minus 371 Days…Are You Equipped?

Mark Rhys Burke, Senior Account Executive, Pilgrim Quality Solutions, an IQVIA company

Two years ago, the European Union (EU) embarked upon a three-year transition period designed to give medical device manufacturers time to comply with new regulatory requirements. The enforcement deadline for compliance with the Medical Device Regulation (EU MDR) is May 26, 2020. That deadline is looming large for everyone in the industry.

That said, I regularly speak to individuals who express trepidation about this rapidly approaching date. They simply don’t have the necessary documents and data prepared to meet the stringent new requirements – and they’re not alone. A recent survey of more than 200 regulatory and quality leaders at major medical device companies showed that 78% of those polled did not have sufficient understanding of the new regulations. (more…)

Putting the Quality in eQMS Software

Putting the Quality in eQMS Software

Stanley Curtis, Head of Software Engineering for SmartSolve EQMS, IQVIA

You rely on an enterprise Quality Management System (eQMS) to manage the quality of your products. Have you stopped to think about the quality of your eQMS? Do you know the level of diligence that your solution provider puts into the quality of the software that powers your eQMS? This is a guideline of what to look for when evaluating an eQMS vendor (or any software solution provider). (more…)

The Future of QMS

The Future of QMS

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

Quality Management has traditionally been an area of manufacturing that was slow to adapt and change to technology shifts in the market. Over the past few years, enterprise Quality Management Software (QMS) systems have stepped up their game and caught up to the market by bringing functionality such as 3rd-party secure access, advanced analytics, and proactive monitoring to their portfolio stacks. (more…)