Why QMS?
We help you innovate, scale, and succeed in the competitive medical device market. Whether you need full-service outsourcing or dedicated resource augmentation, we deliver results you can trust.
Our Differentiators
At Quantum Medical Solutions, we stand out with our expertise and client-centric approach. A key differentiator of QMS is our expertise in Documentation and Technical Writing, ensuring that regulatory submissions are clear, accurate, and fully aligned with compliance expectations. Our documentation services cover clinical evaluations, technical files, risk management reports, and post-market surveillance documentation, expediting approval processes and reducing regulatory burdens.
Combining over two decades of technical (hardware and software development) and regulatory (compliance, certification) knowledge for a holistic approach.
Deep domain knowledge in both traditional medical devices and Software as a Medical Device (SaMD).
Expertise in integrating and validating AI/ML solutions in compliance with global standards.
Seamless integration of industry-leading eQMS platform.
Supporting compliance across all medical devices, from Class I devices to AI-driven SaMD innovations.
IT and Cybersecurity
In today’s digital health landscape, IT and Cybersecurity are critical to medical device success. QMS offers specialised cybersecurity solutions that ensure compliance with evolving global standards such as IEC 62304 and ISO 27001. We help businesses implement robust cybersecurity frameworks, protect patient data, and safeguard medical software against vulnerabilities, ensuring operational resilience and trust in connected healthcare solutions.
Why Partner with Us?
Partnering for Your Success
QMS is more than a compliance partner—we are your ally in driving innovation while ensuring patient safety and regulatory excellence. Whether you’re developing traditional medical devices, launching your first SaMD, or integrating AI/ML technologies, our tailored solutions ensure your success from concept to market.
We manage your projects end-to-end, ensuring quality and timely delivery.
Access highly trained professionals who can work independently or as part of your team, both Onshore and Offshore.
Proven experience in SaMD-specific development, testing, and regulatory compliance.
Flexible Onshore and Offshore options to meet your budget and project requirements.
