Monthly Archives: December 2019

//December

MDIC Releases Case for Quality CAPA Process Improvement Whitepaper

Medical Device Innovation Consortium/MDIC’s Case for Quality program today released a whitepaper recasting the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The whitepaper summarizes the initial findings and recommendations developed by a joint team from [...]

2019-12-19T18:22:20+00:00December 19th, 2019|

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – December 9-13, 2019

This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. For [...]

2019-12-09T15:05:50+00:00December 9th, 2019|