This comprehensive white paper can be helpful for medical device companies to strategically update their risk management process to not only satisfy the requirements of the 3rd Edition of the ISO 14971 standard, but to improve their risk management process.
Many companies are still struggling with the need to transition from a system that once satisfied the ‘requirements’ provided from within the MDD standards, to an improved system that will satisfy the new Medical Device Requirements (MDR). Just how is that accomplished?
The FDA Case for Quality initiative utilizes the Quality System Management (QSM) solution to perform risk analysis, in providing guidance associated with underperforming Quality Systems
The following whitepaper is intended to ensure the alignment of our terminology, and to provide a foundational understanding of the importance of the Quality System Management (QSM) solution in association with the management of medical device Quality Systems.