Impact of EU MDR on Notified Bodies

As medical device companies are beginning to transition towards the EU Medical Device Regulation standards, there is no denying that Notified Bodies are also making strides to meet the May 2020 deadline. According to a recent article, the new regulations include...

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Understanding the FDA Cybersecurity Go-Team

Understanding the FDA Cybersecurity Go-Team

The U.S. Food and Drug Administration (FDA) recently unveiled the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, a comprehensive plan with the goal of assessing processes and procedures in order to enhance medical device security in an ever-evolving technological landscape.

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From On-Screen To Real Life

From On-Screen To Real Life

The US Food and Drug Administration (FDA) recently released a new medical device safety action plan that contains five focus areas that aim to improve the quality of real-world evidence, improve post-market surveillance, spur innovation around safer devices, advance cybersecurity initiatives and reorganize the Center for Devices and Radiological Health (CDRH).

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Find What Works For You

Find What Works For You

Technology is always changing. From new cell phones that help you connect to rockets that go out in to the universe. Technology empowers people to be innovative and create the best results. Stability testing is no different

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Amazon Reportedly Considering PBM Partnership

In a recent Goldman Sachs report, technology giant and retail superpower, Amazon, is detailed as seeking a PBM partner. This would gain Amazon access to the pharmaceutical industry and make it easier for the supplier to take the place of many well-known...

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