Regulatory Services

Quality & Compliance, Assured

With a quality-first mindset and proven regulatory strategies, we help our customers navigate complex quality assurance and compliance requirements across the medical device and digital health landscape. Grounded in deep medtech experience, our disciplined QA engineering and tailored QMS methodologies ensure consistent regulatory alignment, risk mitigation and product safety — so approvals become milestones, not hurdles.

QMS Gap Analysis
We perform comprehensive Quality Management System (QMS) gap assessments against standards like ISO 13485, FDA 21 CFR Part 820 and EU MDR to identify compliance gaps, risks and improvement opportunities in your existing processes and documentation.

Compliance Remediation
Our experts lead focused remediation programs to address audit findings, regulatory nonconformances and legacy system issues, ensuring alignment with FDA and MDR expectations while preparing your QMS for future scalability.

Quality Assurance Engineering
We embed QA engineering into the product lifecycle to drive quality upstream, by creating test plans, authoring test protocols and delivering test reports. Our engineers apply verification and tracing to comply with ISO 13485 and 21 CFR 820.30.

Cybersecurity Assessments
We assess your software and connected devices for vulnerabilities and regulatory compliance under frameworks like FDA Premarket Cybersecurity Guidance, ISO/IEC 27001, and NIST 800-53, helping safeguard your product and protect patient data. Learn more about our cybersecurity solutions. Read more

Product Testing
From functional and usability testing to performance and validation protocols, we design and execute test strategies aligned with IEC 62366, FDA Human Factors Guidance and ISO 13485, ensuring your product meets safety, quality and regulatory expectations. Learn more about our testing services. Read more