Medical Devices
If you’re a medical device manufacturer aiming to market your product in the European Union, understanding the Declaration of Conformity (DoC) is crucial.
Medical Devices
Software as a Medical Device (SaMD) is transforming the future of healthcare, enabling innovative diagnostics, real-time patient monitoring, and advanced clinical decision support.
Medical Devices
Gaining FDA approval is a pivotal milestone for any medical device manufacturer seeking to enter the U.S. market.
Medical Devices
Entering the global medical device market is a complex journey that requires a deep understanding of diverse regulatory landscapes. From the United States to Japan, each country has its own set of rules, timelines, and expectations.
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.
