The organization ensures full regulatory and quality compliance with international standards and governing bodies, including MDR (EU Medical Device Regulation), FDA (U.S. Food and Drug Administration), CFDA (China Food and Drug Administration), DRAP (Drug Regulatory Authority of Pakistan), WHO (World Health Organization), and relevant ISO standards. All systems and processes are implemented, maintained, and continuously improved to meet these global requirements, ensuring product safety, perform.
The Management System, implemented in accordance with ISO standards, ensures consistent quality, regulatory compliance, and continuous improvement across all operations. It integrates key processes such as development, production, and documentation within a structured framework that also governs cleanroom management. This approach maintains controlled environments, product integrity, and operational efficiency throughout the organization...
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.