On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...
Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and by ensuring effective oversight of quality and regulatory reporting ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...
On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...
For many industries and applications, implementing inspection at the point of assembly improves quality of the supply chain while reducing the impact of downstream detection of defects. Eliminating ...
When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...
The medical technology sector has been a leader in innovation for a long time, and now the regulations are changing accordingly. As a result of digital transformation and worldwide ...
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