March 21, 2023 Problem Containment Actions for Controlling Regulatory Impact Today I received a question wrestling with the fact that problem containment actions tend to primarily focus on product containment and patient impact/risk, while not so much on containment actions aimed at controlling regulatory risk. This reminds me of ISO 13485’s deliberate distinction between […]
<h1 class="entry-title">Category: Risk Management</h1>
What if I Add an Expiration Date for Risk Reduction?
February 24, 2023 What if I Add an Expiration Date for Risk Reduction? If, to reduce risk, you are adding an expiration date to a medical device model for which previously-marketed units do not have such an expiration date, then, generally speaking, the governing regulatory authorities will reflexively suspect/assert that a recall might be […]
EU MDD and MDR “AFAP”
January 26, 2021 EU MDD and MDR “AFAP” Check Your Existing Procedures: To properly attend to what Europe’s outgoing Medical Devices Directive (MDD) and new Regulation 2017/745 (the EU MDR) require regarding the reduction of risk “as far as possible” (AFAP), it is first important to know what an organization’s corresponding acronym actually […]