Global regulatory agencies are adopting more medtech-focused digital solutions, such as EU EUDAMED, the FDA eSTAR 510(k) program, and the Chinese eRPS, to improve information processing efficiency and reduce agency costs. However, many medtech companies still struggle with outdated and manual word processing solutions that are administratively burdensome.
Time-to-market is a critical competitive advantage for medtech companies, and so is the ability for them to keep up with the evolving regulatory landscape. Digital transformation is key to both outcomes, as a sweeping change to regulatory affairs is currently underway.
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