Medical Devices
Jodi Granger is the Director of Regulatory Affairs at RegDesk.
Medical Devices
In the highly regulated medical device industry, quality and compliance are non-negotiable. ISO 13485, the international standard for Quality Management Systems (QMS) in the medical device industry, plays a critical role in ensuring that manufacturers meet regulatory requirements for medical devices and in-vitro diagnostic products.
KSA
The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to companion diagnostic IVDs
Medical Devices
Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.
EU
The new article provides clarifications regarding the transitional arrangements associated with the changes in the legal framework.
