At Exa, we thrive on collaboration, and it’s been fabulous working with Kelly Coverdale. Her expertise and leadership in Design Controls and Risk Management are invaluable in guiding medical devices through the regulatory landscape. We’re thrilled to be partnering with the Cover Biomedical team, tackling the complexities of product development and regulatory submissions with precision and innovation. Likewise, it’s been a pleasure to collaborate with Carla Zampaglione and the team at Sento Solutions Pty. Ltd. ensuring Usability Engineering and Human Factors inputs are delivered to the highest standards for FDA 510(k) submission. Bringing life-changing medical technologies to market takes the right expertise, partnerships, and execution—and we’re proud to be part of this journey! #MedicalDevices #RegulatoryAffairs #HumanFactors #ProductDevelopment #DesignControls #RiskManagement #ExaInnovation #Collaboration
I'm currently working alongside Carla Zampaglione and her team at Sento Solutions Pty. Ltd. to develop compelling Human Factors content for an upcoming FDA 510(k) submission. Simultaneously, I'm partnering with Stephen Leahey, Sarah B., and the Exa Product Development team to provide comprehensive product development support and navigate the intricacies of medical device lifecycle considerations for a significant regulatory submission. Both teams are an absolute pleasure to work with in my role as a Program Manager, delivering Design Controls and Risk Management support at Cover Biomedical. #riskmanagement #designcontrols #medtech #medicalindustry #innovation #medicaldevices