Exeed is happy to introduce our new webinar series, Sharing Knowledge, Solving Problems, hosted by Dr. Naveen Agarwal. These interactive webinars are an opportunity for the medical device community to come together and discuss questions and obstacles surrounding ISO 14971 and risk management.
Read MoreClause 4.2 of ISO 14971:2019 requires the top management to define and document a policy for establishing criteria for risk acceptability. This policy must provide a framework to ensure that criteria are based on applicable national or regional regulations and relevant International Standards, stakeholder concerns and generally acknowledged state of the art.
Read MoreFDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.
Well, it’s about time!
Read MoreA warning letter is the agency’s way of giving you a final chance. Behave, or you will face painful enforcement actions such as a recall, seizure, civil money penalties, or worse still, jail time for responsible individuals. It carries a big stick, and predictably, manufacturers have been quite fearful of receiving a warning letter.
Read MoreCongress first added the Least Burdensome provisions to the Food, Drug and Cosmetics Act (FD&C) through Food and Drug Administration Modernization Act (FDAMA) of 1997. Additional provisions were added through the FDA Safety and Information Act (FDASIA) in 2012 and the 21st Century Cures Act (Cures Act) in 2016.
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