The Importance of Labeling
Labeling issues continue to plague the medical device and pharmaceutical industry. The FDA recently released a statement regarding a medication recall as a result of a labeling error. CBS News reports, “Accord Healthcare Inc. is voluntarily recalling one lot of 12.5...
Navigating the Evolving Pricing Landscape
Over the past decade, there has been a significant shift in medical device purchasing, pricing, reimbursement and support. Several professionals in this industry, including medical device manufacturers, health systems, as well as patients have had to adjust to the...
Can UX Save Lives?
Human factors and usability testing professionals play an integral role during medical device design and post-market operations. In order to ensure medical devices are intuitive for HCP and patient use, human factors teams must develop safety validation strategies and...
Exploring 5 Trends in Enterprise Labeling
Navigating and staying ahead of the curve in the labeling industry can be challenging. There are evolving technologies, regulations and trends to keep in mind. Manufacturing.net recently published a two-part article that explores the challenges within enterprise...
What’s Next? Brexit, Medical Devices and Beyond
As regulatory professionals continue to adapt to EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), another challenge that many in the medical device industry face is the reality of Brexit. As a result of the changing regulations, there is...
Nichol Goldstein – Kaspersky Lab
Executive Leadership Support Forum: Boston: Speaker Interview
Brian DiVasta – Genzyme
2nd Annual Pharmaceutical Manufacturing Execution Systems Conference: Speaker Interview
Gilad Langer – NNE
2nd Annual Pharmaceutical Manufacturing Execution Systems Conference: Speaker Interview
Christian Berg – Genentech
2nd Annual Pharmaceutical Manufacturing Execution Systems Conference: Speaker Interview
Pamela Chaves – STAG Industrial
Executive Leadership Support Forum: Boston: Speaker Interview
FDA Clears First Medical Device Accessory for Apple Watch
The U.S. Food and Drug Administration cleared a device known as the KardiaBand on Thursday. The device is embedded in an Apple Inc watch band that monitors a user’s heart rate, detects when something is amiss and prompts the user to take an electrocardiogram. Read the...
Data Visualization in Medical Communication
It is estimated that medical information and knowledge will be doubling every 73 days. Medical professionals and researchers now have to find the best way to attain this knowledge quickly in a clear and understandable format. A solution that has been presented is data...
FDA Approves Pill With Digital Tracking Device You Swallow
Japan-based Otsuka Pharmaceutical Company announced the approval of their medication system. The pill with a built-in digital tracking device will be used in a psychiatric setting to help treat schizophrenia, a psychotic disorder, which includes symptoms...
Food Industry Blindsided as Trump Administration Supports Obama-Era Menu Labeling
Recently, the Food and Drug Administration issued a surprising preliminary guidance for the posting of calorie counts to take effect on May 7, 2018. This regulation will apply to food-service establishments and supermarkets that have 20 or more locations...
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