Incorporating Quality by Design as a MedTech Startup
As a medtech startup, you have an idea that could perhaps change lives. But how do you ensure your innovation works and is safe, effective, and scalable?
Posts by
Monica Williams
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.
Key considerations in 510(k) submissions for AI-enabled products
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.
Cultivating a Quality-First Culture at a Medtech Startup
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.