Tag Archives: survey

Planes, trains, and device regulation – the fatigue of regulatory challenges: MTI REGULATORY REPORT 2024 (part 1)

By Rich West

MTI Regulatory Report 2024 data overwhelmingly suggests regulatory resources throughout the industry are being stretched. Time/Bandwidth is the top medical device regulatory challenge faced during 2024, potentially leading to industry-wide regulatory fatigue and driven by changing global compliance regulations in recent years.

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Regulatory Survey

Medical Device Regulatory Report 2024 – Executive Summary

By Celegence
Regulatory Survey

The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data validates industry concerns of increasing workloads and overtime hours, and how many companies are finding it hard to recruit suitable skilled regulatory associates. Medical device company RA/QA teams raise concern about deficient competencies and resource availability with increasing regulatory complexity and changing global requirements.

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