How ISO 13485 Supports FDA QMSR Compliance
Learn how ISO 13485 supports compliance with the FDA Quality Management System Regulation, where FDA-specific requirements remain, and how medical device manufacturers can prepare.
What is ISO 13485?
What is ISO 13485? ISO 13485 is the standard for maintaining a quality management system (QMS) in the medical device industry. Laboratories or businesses that provide or use medical devices must demonstrate best practices and provide safe, effective, and high-standard...
How to get ISO 13485 certification
If you’re a medical device manufacturer, it’s likely that ISO 13485 will be on your radar. This internationally-recognised standard ensures such vital technology as yours is safe, effective, and delivered to a high quality. Not only does the certification help...
NHS ISO13485 Donation Effort
In the last few weeks communities and businesses have come together in response to Covid-19 and to show support for our NHS. Seemingly overnight, companies started developing systems to help with producing masks, lab coats, ventilators, and other lifesaving equipment...
