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Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities. Read More
The National Electrical Manufacturers Association (NEMA) released a new quality management standard for servicing medical imaging equipment—designed to ensure equipment is returned to a safe and effective condition for its intended use. Read More
At least three complaint cases evaluated by the FDA lacked the required root cause investigations or rationale for not initiating investigations. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
The shift to increased patient input for device development and clinical trials in recent years has been more challenging than expected, according to participants at the FDA/CMS Summit. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate device history records. Read More
The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More
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