Wearable and Home-use Devices: QMS

Presented by Kyle Rose, CEO of Rook Quality Systems

Building a compliant Quality Management System for wearable and home-use medical devices comes with unique challenges, especially when resources are limited and regulatory demands keep evolving. In this webinar, Kyle Rose, CEO of Rook Quality Systems, breaks down what it takes to design and maintain a QMS that's both audit-ready and scalable as your company grows.

What we'll cover:

• Key QMS requirements specific to wearable and home-use device manufacturers
• How to identify and close compliance gaps without overwhelming your team
• Strategies for building a scalable QMS that grows with your business
• Practical steps to accelerate market entry while staying regulatory-ready
• How QMS design documentation, software documentation, risk management, and testing requirements intersect and what that means for your design software workflows

Whether you're a startup navigating your first QMS build or a mid-sized company optimizing an existing system, this session delivers actionable insights tailored to your stage of growth.