How MedTech manufacturers can move cybersecurity upstream, strengthen traceability, and prepare for faster vulnerability response.
The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action.
Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?
Rene Zoelfl, Global Industry Advisor for PTC’s MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.
omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.
To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.
In a document updated for the first time since 2017, AAMI released new guidance for EO material compatibility and including new alternatives.
North Carolina healthcare provider supplies clinicians with immediate, on-site access to 3D-printed anatomic models and support through Ricoh Managed Services.
Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.
The healthcare sector can expect some improvement in lower inflation rates and attendant pressures for the remainder of 2024. But it’s not yet out of the pandemic woods, as interest rates remain high, the shortage of professionals persists and there’s no shortage of risks. Here’s a perspective on what the year holds.