We specialize in regulatory strategy, MDR compliance, validation, clinical evaluation, and usability engineering for health technology companies — helping you bring safe, effective products to market with confidence.
Collaborating with global medical device companies to navigate MDR, FDA, and ISO compliance with precision and trust.
Delivering end-to-end support that ensures faster approvals, reduced audits, and seamless market access across regions.
Driving quality and compliance in every project to uphold global safety standards and enhance healthcare outcomes.
Our expertise spans the entire spectrum of medical device regulatory and certification services. We specialize in guiding manufacturers through MDR, FDA, and ISO compliance — from concept development to successful market approval. Our team delivers excellence in validation, clinical evaluation, and testing, ensuring every device meets the highest standards of safety and performance.
We simplify the FDA and regulatory journey by providing expert guidance and education at every stage. Our team helps you identify product-specific requirements, build a tailored strategy, and accelerate market approval with efficiency and confidence.
Our team helps you map out a clear, customized regulatory plan that aligns with both your product and target markets. From pre-submission planning to documentation and approval strategy, we ensure your compliance journey is precise, efficient, and globally aligned.
Clinical validation can be challenging to navigate. From planning to execution, we work alongside you to create a study approach that supports your product goals and meets regulatory expectations. Our global experience ensures compliance and success in both the U.S. and abroad.
The right clinical strategy defines success. We develop tailored study plans that connect product innovation with regulatory requirements, optimizing time and cost. Our team supports you through every step,domestically and worldwide.
We align your QMS with the natural evolution of your product. From initial design to market maturity, our expertise spans FDA QSR and ISO 13485 standards—supporting both hardware and software medical technologies.
As your product evolves, so should your quality system. We build adaptable QMS frameworks that meet FDA, MDR, DRAP, WHO and ISO requirements, ensuring compliance and efficiency for every stage of your device’s journey.
We partner with medical device innovators to navigate the complexities of global regulatory landscapes with precision and confidence. Our expertise spans FDA, MDR,WHO, DRAP and ISO frameworks—supporting you through product validation, clinical study design, and execution to ensure safety, performance, and compliance. From Design and Development Risk Assessments and technical documentation to quality management systems and post-market surveillance, we deliver integrated regulatory strategies that align with your product’s life cycle. With our guidance, your innovations move efficiently from concept to compliant market access—globally.