About Quarem
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Why We Exist
Our Passion. Our Purpose.
From early development through global market access and post-market compliance, Quarem works hand-in-hand with startups and global enterprises across MedTech—including medical devices, in vitro diagnostics, and medical device software such as SaMD and SiMD—to bring life-changing products to market with confidence and care. Guided by a commitment to excellence and innovation, our work helps advance new technologies and deliver safe, effective medical solutions to patients around the world.
"What sets Xiaoyi apart is her ability to translate complex regulatory language into practical, actionable steps, making her a trusted advisor across cross-functional teams—from R&D to manufacturing to executive leadership. Her guidance was instrumental in training our staff in inspection readiness and audit best practices, significantly improving our internal compliance culture. Her professionalism, reliability, and collaborative spirit made her an invaluable extension of our QA/RA team. Her work has had a lasting impact."
– Mark Marosz, Director, Quality Assurance and Regulatory Affairs, Complete Genomics
What We Do Best
Rooted in Knowledge. Designed for Impact.
With decades of experience in quality, regulatory affairs, and engineering, Quarem delivers expert, actionable guidance in quality and regulatory affairs. Our distinct advantage lies in combining strategic insight with hands-on execution—supporting clients as they navigate complex regulatory landscapes and build high-performing quality systems.
"We had the pleasure of working with Xiaoyi during an important stage of our MDR compliance efforts for our legacy SaMD product. Over the course of six months, she provided clear, practical training on IEC 62304 for software lifecycle processes, developed and updated SOPs, revising key portions of our technical documentation, and guided our post-market surveillance activities. Xiaoyi collaborated closely with our internal team, contributing practical tools, thoughtful insights, and a supportive, positive approach."
– David Russo, Senior Director Regulatory Affairs, Quality Systems Expert, Mach7 Technologies
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How We Work
Built on Principles. Proven in Practice.
Our approach is grounded in partnership, transparency, and excellence—principles that shape how quality and regulatory challenges are solved. By simplifying processes, clarifying documentation, and delivering results that drive real progress, we enable MedTech companies to move faster, operate with confidence, and stay focused on advancing their business.
I hired Xiaoyi Wang at Quarem Consulting during a pivotal period for a SaMD startup that was in a critical growth stage, transitioning from IVDD to IVDR. She brought exceptional expertise, strategic insight, and a calm, results-focused approach. What sets her apart from other consultants is her ability to see the big picture while diving deeply into technical details—all while remaining approachable, collaborative, and easy to communicate with. She bridges the gap between technical teams and leadership, aligning everyone toward a shared objective.
– Trevor Hawkins, Director US DOE Human Genome Project, Healthcare & Technology Industry Disruptor, Board Member & Advisor