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Medical Device

Medical Device Labeling under FDA

EU Regulations: Things Still to be known

FDA Issues New Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers during COVID-19 Emergency

Medical Device Change Control Process

Danish Medicines Agency: Newly Improved Reporting Requirement to Strengthen the Surveillance of Medical Devices

USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

The First Step

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