5 Key Differences Between DCGI and CDSCO
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs, medical devices, and cosmetics. It operates under the Ministry of Health & Family Welfare and...
CE Marking of Digital Health Technologies: EU MDR Guidelines
Digital health technology is the integration of digital tools into healthcare to improve prevention, diagnosis, monitoring, and treatment. CE marking of digital health technologies is mandatory under the EU Medical Device Regulation (MDR). It ensures that software,...
10 Best Practices for Internal Auditing of ISO 13485:2016 QMS
Internal auditing of ISO 13485:2016 QMS aims to verify compliance, identify nonconformities, and strengthen the medical device quality system. This structured process ensures audit readiness, regulatory alignment, and continuous improvement. Internal auditing of QMS...