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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