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.
Medical Devices
Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.
Medical Devices
Mastering regulatory change management is crucial for medical device companies to stay compliant and competitive in a rapidly evolving regulatory environment.
