Excessive focus on compliance can create hurdles in cultivating quality and innovation.
Although an expensive and challenging regulatory market, Japan’s aging population offers plenty of opportunities for device companies.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
Failure to comply with FDA’s wishes landed three companies warning letters.
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
It’s critical to understand the characteristics of this country’s market to determine the most effective steps.
The 15-mm valve size is small enough to use in newborn patients to treat heart defects.
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
Audits are the cornerstone of a QMS.
In many cases, establishments are removed due to a failure to renew annual registration with the agency.