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...
CE Marking for Ophthalmic Medical Devices
Ophthalmic medical devices are specialized instruments and equipment used to diagnose, monitor, and treat eye conditions. These devices range from simple diagnostic tools to advanced therapeutic and surgical products. CE marking is critical for ophthalmic medical...
EU MDR Declaration of Conformity for Medical Devices: Insights
The EU MDR declaration of conformity (DoC) is a legally binding document required under EU medical device regulation (MDR). Every medical device manufacturer must issue the DoC before placing a device in the European market. It serves as the manufacturer’s formal...