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Monica Williams, QA/RA Manager at Enhatch, leads in implementing and optimizing highest standards of quality and QMS frameworks as well as regulatory strategy and compliance to improve patient outcomes and advancing the intersection of technology and healthcare.
When you are developing an AI-enabled medical device, one thing is clear: getting your 510(k) submission right is crucial. It can be a daunting task, but with the right approach, you can streamline the process and increase your chances of success.
As the QA/RA Manager at Enhatch, I take immense pride in our organization's commitment to product excellence and patient safety. Enhatch is focused on helping medical device companies, hospitals, and distributors easily plan, manage, and scale patient-specific solutions.