Tim Xu, Ph.D., MBA
CEO
About Akunyx
We build usable compliance for regulated MedTech
Akunyx is an AI-powered platform that unifies eQMS and ERP so quality, operations, and compliance move together. We’re engineers and operators who have shipped regulated software and devices—and we design for auditability from day one.
Mission, Vision, and Value Statements
Mission Statement
To empower regulatory industries by providing AI-powered quality management systems that streamline compliance, enhance operational excellence, and accelerate the safe delivery of life-improving technologies.
Vision Statement
To lead the future of MedTech by integrating AI-powered eQMS and ERP systems that enhance quality, efficiency, and regulatory confidence.
Value Statement (A·K·U·N·Y·X)
A
Agility
We adapt quickly to evolving regulatory, technological, investor, and customer needs—without compromising quality or compliance.
K
Knowledge
We continuously expand our understanding of global regulatory frameworks, emerging technologies, and customer challenges to keep our solutions insightful and future-ready.
U
Unity
We believe in collaborative innovation, uniting expertise across AI, quality systems, and life sciences to achieve common goals that advance the industry.
N
Navigability
We simplify complex compliance landscapes, enabling clients to navigate FDA, ISO, and EU MDR requirements with clarity and confidence.
Y
Yield through Integrity
We measure success not only by outcomes but by how ethically and responsibly they’re achieved, creating sustainable value for customers and stakeholders.
X
eXcellence
We commit to technical precision, customer satisfaction, and continuous improvement—ensuring every release exceeds expectations.
Our Story
Akunyx began with a shared frustration—and a shared vision. Our founders have spent decades across the medical-device lifecycle: hardware and software development, NPI, R&D, manufacturing, and regulatory compliance. We’ve seen innovation slow under fragmented systems, version chaos, and siloed processes.
With deep experience in cloud-native platforms and regulated delivery, we built the tool we wished we had: an AI-powered quality system that unifies product, quality, regulatory, and operations in one audit-ready environment. Today, Akunyx helps life-sciences teams move faster, stay compliant, and bring transformative products to market with clarity and confidence.
Leadership
Rishabh Ostawal
CTO
Haidong Peng, Ph.D.
CDO & CFO
Join our pilot program
If you manage quality or operations in a regulated environment, we’d love to collaborate.