In this video, we explain the concept of Design Control, a mandatory requirement by the FDA and ISO 13485 in the medical devices industry. You’ll learn which medical device classification requires design control, how it applies to quality management, and the key steps to follow in the design control process.
Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ...
As the life sciences industry becomes increasingly regulated and competitive, quality management has become more vital than ever. Are you confident ...
The right electronic Quality Management System (eQMS) can help strengthen your compliance processes and build a culture of quality within your ...
In life sciences, especially if you’re in the medical device industry it becomes harder to manage projects in accordance with your company’s quality ...