Dr. Abtin Rad
Dr. Abtin Rad

New Cybersecurity Standards for Medical Applications

By Dr. Abtin Rad

Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.

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Jenna Wagner
Jenna Wagner
Soapbox

Life Sciences Labeling for Patient Safety

By Jenna Wagner

Life sciences companies have a lot of factors to consider when it comes to labeling. Understanding the global labeling regulations for patient safety and how enterprise labeling solutions can help companies achieve compliance while assuring speed to market, and labeling system validation and auditability, can save resources and reduce costly errors.

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SOTA
SOTA

State-of-the-Art: Unpacking MDR’s Evolving Requirements

By Elisabeth Liljensten, Lina Burman, Mark Cabonce, M.S., DABT, Monica Grekula

Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.

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Dan Golder, Impact Advisors
Dan Golder, Impact Advisors
Soapbox

Next-Generation Enterprise Asset Management

By Daniel Golder, DDS, MBA

Standalone best-of-breed Enterprise Asset Management (EAM) systems have historically been leveraged to help solve the transactional needs of clinical engineering, IT and facilities. Yet few organizations are currently capitalizing on the wealth of data generated from these systems. In this article, we’ll examine some of these opportunities and offers suggestions as the industry begins developing our “next generation” of EAM systems.

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