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By Mauricio Rodriguez – Think about it this way; when you change something what else could be impacted by the change? Could the change also have some other unintended consequences? This is equivalent to a “regression analysis” in software, here is how to do it for your medical device.
By Mauricio Rodriguez – Interpreting FDA QSR Subpart 820.100(a)(4) – “Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device”
By Mauricio Rodriguez – In mid-2020 new European Union MDR regulations were set to go into effect, replacing those that were set back in 2017. Due to COVID-19, this has been delayed by the European Commission, making them effective May 26th, 2021. However, it is never too early to start adapting to the EU MDR regulatory changes.