“Medical device companies aren’t worried about the FDA as much as they are about the EU MDR transition”. This comment was recently made by a device industry professional during a dinner conversation, and it resonated with me. Of course, I was compelled to offer my opinion in response, which I also expand on in this post.
Medical device companies need not worry about either. A strategic, risk based, and proactive approach to transforming their Quality Management System implemented today, will negate the need to remediate their system under duress tomorrow. The choice is theirs and theirs alone. Additionally, it is the responsible choice to ensure the satisfaction of all stakeholders. Business stakeholders, worldwide regulators, and most importantly… the people who are the patients and users of the medical device.
I believe FDA CDRH is relying less upon enforcement as the primary mechanism to influence behavior, and fast becoming primarily focused upon forwarding the progress of a medical device industry to instead pursue a ‘culture of quality’ to achieve better results, such as has already occurred within other industry sectors such as automotive and semiconductor.
Let’s talk about a business friendly transformation plan for your QMS.
 (EU) 2017/745 of the European Parliament and of the Council, 117 Official Journal of the European Union 1 (Apr. 5, 2017) [EU MDR]
 FDA CDRH Mission | Vision | Shared Values, https://www.fda.gov/about-fda/about-center-devices-and-radiological-health/cdrh-mission-vision-and-shared-values