Where MedTech Innovation Meets Market Success
Compliance Simplified.
Quality Amplified.
End-to-end solutions for navigating the complex landscape of
regulatory compliance and market access
Meet Quarem
Your Partner in MedTech Excellence
With decades of quality and regulatory expertise, we help MedTech innovators turn complex regulatory challenges into actionable solutions.
From early development through commercialization and scale-up, we guide developers, manufacturers, and distributors of medical devices, IVDs, and medical device software to navigate regulatory requirements and build robust quality systems.
Whether you’re starting from the ground up or expanding an established operation, our expertise accelerates your path from innovation to market—with clarity, confidence, and compliance.
Why Clients Trust Quarem
Our Services
Whether you’re preparing your first regulatory submission or managing global compliance across a growing portfolio, Quarem meets you where you are. Our hands-on approach and tailored solutions support organizations of all sizes—from startups to global companies—helping them bring safe, effective, and compliant products to market.
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Our strategic and operational services span the full development and commercialization lifecycle for medical devices, in vitro diagnostics (IVDs), Software as a Medical Device (SaMD), and Software in a Medical Device (SiMD)—each with its own complexities and specialized requirements. By working hand-in-hand with your team, we turn these services into practical, actionable results, so you can focus on what matters most: your innovation.
Global Regulatory Strategy & Submission
International Standards Compliance
Quality Management System (QMS) Development
US FDA and IVDR/MDR Requirements
Medical Device Software (SaMD & SiMD)
Resource Augmentation & Enablement
About Quarem
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 to bring life-changing medical devices, in vitro diagnostics, and medical device software—including SaMD and SiMD—to market with confidence and care.
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"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.
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​​"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
How We Work
Built on Principles. Proven in Practice.
We believe the best results come from strong partnerships, open communication, and a commitment to excellence. These principles guide how we work with you—helping your organization tackle regulatory and quality challenges, simplify complex processes, and achieve tangible results.​
Our Clients
From startups to Fortune 500 companies, we have a combined 75+ years of experience in the medical device industry.
