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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Harsha Rajasimha, Ph.D.
Harsha Rajasimha, Ph.D.

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research

By MedTech Intelligence Staff
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Genomics data scientist Harsha Rajasimha, Ph.D., Founder and Executive Chairman of IndoUSrare, highlights the risks of developing AI/ML algorithms based on biased data, as well as efforts underway to improve global collaboration on the collection and sharing of health data that may help us realize the potential of AI in diagnoses and treatment of rare diseases.

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Cybersecurity
Cybersecurity

Preparing for the PATCH Act and RTA

By MedTech Intelligence Staff
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The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of  Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.

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Renée Bailey
Renée Bailey

Instructional Materials: The Basis for Safety Between Users and Medical Devices

By Renée Bailey
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Instructional materials help users grasp how to use a device safely. Renée Bailey, Certified Instructional Technologist (CIT), explains how effective instructional materials are vital for the medtech design process, and shares necessary considerations to produce instructions that are coherent, easy to understand and aligned with the human factors engineering process.

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