The MedTech Intelligence 13485:2016 Virtual Conference
Aligning the standard to ISO 9001 and 14971, the QSR and other regulations
The final version of ISO 13485:2016 was recently published, requiring significant changes in human resources, management responsibility, and many aspects of the quality management system, including a risk-based approach to process development, greater focus on supplier controls and software validation, enhanced planning activities, new documentation requirements, and retroactive remediation for legacy products and systems, among many others.
In addition to the changes required by the new version of 13485, companies will struggle with the overlapping but different requirements of 9001, 14971, the Quality System Regulation, the impending update to the Medical Device Directive, and other standards, regulations, and guidances. What are the best approaches to establishing procedures that comply most effectively with all relevant requirements with minimal duplication of effort?
Copyright © Innovative Publishing Co. LLC; PO Box 817 Washington Crossing, PA 18977 USA