A Closer Look at State-of-the-Art Clean Room Packaging & Assembly In the medical device industry, it’s the topic on everyone’s minds, at all times. And for good reason: risk affects patients and outcomes, supply chain and productivity, manufacturers’ reputations, and companies’ bottom lines. Risk can take many forms, one of them being…
Navigating Converting Your Product Lines to Sterile Packaging In spring 2017, the European Parliament approved and formally adopted the EU Medical Device Regulation (MDR). In brief, the MDR is a regulatory push to increase medical device safety in the EU market. It specifies that devices delivered in a sterile state should be designed,…
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Recall Processing: How to Contain Risks and Costs in Voluntary and Mandatory Recalls This topic is the one that no manufacturer ever wants to talk about. No OEM wants to be subject to a federally mandated recall or undertake a voluntary recall. Recalls of any kind are bad for patients, for reputations, for…
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