Cognidox, a leading provider of electronic Quality Management Systems (eQMS) for medical device and life science companies, today announced the ...

Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the ...

ManaMed LLC, a leading innovator in medical device solutions, proudly announces its certification to ISO 13485 ...

These requirements are defined in ISO 13485, the international standard for medical device quality management systems, as well as in 21 CFR 820 and other global regulations. Benefits of Attending ...

The Food and Drug Administration has published final guidance for the cybersecurity of premarket medical devices. The new document presents FDA’s latest ...

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June ...

A World Bank-supported health project started in 2021 to contain the COVID-19 pandemic in Ukraine rapidly pivoted to help the country’s healthcare system respond to urgent needs caused by Russia’s ...

Collaboration with French MedTech company, TISSIUM, has resulted in FDA approval for unique 3D-printed polymeric solution for ...

KCS notified as authorised body to inspect medical devices manufacturing facilities. Kalam Institute of Health Technology Certification Services located on AMTZ campus is the only one operational ...

Chronic pain is a debilitating condition that severely impacts quality of life, often leading to reliance on opioid medications with their severe side effects and addiction risks.

Violations related to quality management systems accounted for approximately 10 percent of all recorded violations at medical device factories in 2024. Meanwhile, violations concerning ...