Tag Archives: risk management

Wearables, adhesives

Beyond Innovation: Confronting the Complex Risks in Health Technology Development

By Justin Kozak
Wearables, adhesives

Wearables are changing the game for health monitoring. From smartwatches and rings to skin patches, glasses, and even bras, companies are in a race to bring the latest innovations to market. But as this trend gains momentum and competition heats up, so do concerns about potential risks like data privacy, cybersecurity vulnerabilities, and the possibility of inaccurate health readings that could critically impact user safety.

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Risk Management in Medical Devices: Harmonizing ISO 14971-2019 & FDA QMSR

By Prasad Ravichandran 

nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.

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Cybersecurity

Managing Legacy Technology Security

By MedTech Intelligence Staff
Cybersecurity

A new guide from the Healthcare and Public Health Sector Coordinating Council recommends cybersecurity strategies that manufacturers and health providers can implement for legacy medical technology as a shared responsibility in the clinical environment, and provides insights for designing future devices that are more secure.

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Anna Cluet

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

By Anna Cluet
Anna Cluet

Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.

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SOTA

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

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

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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