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The use of risk management per International Organization for Standardization (ISO) 14971 has been long-established and is typically well understood within the medical device development industry. However, with forthcoming updates to ISO 13485:2016 just on the horizon, there will be an even greater importance placed on utilizing risk-based decision making and planning for quality system elements unrelated to design controls. These changes will require further learning and understanding by medical device manufacturers well in advance of the mandatory compliance date of March 31, 2019.
Join NAMSA on October 19 (10-11 a.m. U.S. ET) as Rich Granquist, Medical Research Manager, discusses the critical steps that medical device manufacturers should take now to effectively incorporate documented risk-based quality systems in preparation for the new regulatory requirements.
Highlighted will be best practices, suggestions and information surrounding:
Time will also be allotted for Q&A.