Insights
Manufacturing Site Changes and Their Impact on Existing Licenses
In the medical device regulatory lifecycle, approval is not the finish line...
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Labeling and IFU Changes That Trigger Regulatory Scrutiny
Labeling and Instructions for Use (IFU) are often perceived as administrative updates—something...
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What Constitutes a Major vs Minor Post-Approval Change Under India MDR?
Once your medical device is approved in India, many manufacturers assume the...
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SaMD Classification Conflicts and Their Regulatory Impact
Software as a Medical Device (SaMD) is enabling faster innovation, smarter diagnostics,...
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