Warren Lesack
Warren Lesack

EU MDR: Ensuring Labeling Compliance

By Warren Lesack
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EU MDR requires significant reforms to the device labeling process. Manufacturers must ensure that identifiers are correctly applied to products, and that key data elements and formats are accurate. In addition, manufacturers need to have access to centralized data, audit tracking, robust security controls, eSignature capabilities and strong workflow management to ensure compliance.

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Peter Muller
Peter Muller

E-labeling: The Road to Reduced Medical Device Packaging Material

By Peter Muller
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New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.

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Jack Cronenwett, MD
Jack Cronenwett, MD
Reimbursement Report

How Real-World Evidence Helps Medical Device Manufacturers Drive Value

By Jack Cronenwett, MD
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More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.

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