It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be critical to comply with such a disparate group of regulations working with so many regulatory bodies. These new regulations and others already on the books reemphasize the importance of having an automated QMS with integrated quality processes tailored to the increasingly complex demands of medical-device regulatory compliance.

 …