Digital Design Control for Medical Devices

Medical Device companies have to manage complexity and regulation without placing excess overhead on their designers. Devices complexity has led to increased complaints, CAPAs, observations, and recalls. The root cause is frequently insufficient and cumbersome design control. Digitalization helps them design with agility while maintaining control. It improves speed, accuracy, and productivity by automating submissions,

Medical DevicesMedical Devices Manufacturers Software Selection Guide for 2018

Tech-Clarity’s Medical Devices Manufacturers Software Selection Guide for 2018 helps manufacturers identify the right buying criteria for software solutions to support developing, producing, and servicing medical devices. For 2018, the guide has also been updated to include additional considerations for the Internet of Things (IoT). This buyer’s guide also takes into account unique needs for medical device

Putting the Q in PLM (PTC does quality management)

I had the chance to talk with … PTC about the important role that PLM plays in ensuring product quality. PTC shared their views on quality and reliability and followed up by giving me some detailed insight into their Relex reliability management solution and how it fits into the PLM ecosystem. It turns out PTC

Quality Risk Management in Life Sciences

Tech-Clarity’s new report Quality Risk Management in Life Sciences: Preventing Failures, Protecting Patient Health reviews manufacturers’ experiences in using Quality Risk Management (QRM) to proactively reduce risk in the Life Sciences industries. Explains how QRM software can be used to efficiently manage risk by sharing quality knowledge across the enterprise and closing the loop on product

Going One-to-One with QLM-plus Vendor MasterControl

I had the chance to talk with … a couple of vendors this year about Quality Lifecycle Management, or QLM. I posted earlier about What I Learned: Expanding PLM’s Pervue – Quality and Risk Management and promised to follow up with some more detail on the vendors. Here are my thoughts on my conversations with MasterControl. Before I get started, it’s important to state up front that MasterControl is not a pureplay QLM suppplier, but a broader solutions company that has strong capabilities in document management coupled with a history of helping companies in regulated industries. More on that later.