Rene Van Melick
As the regulatory landscape evolves, it is crucial for manufacturers of drug-device combination products to stay compliant. The upcoming 21 CFR Part 820, which involves compliance with ISO 13485:2016, also known as the Quality Management System Regulation (QMSR), introduces stringent requirements that align with international standards to ensure product safety, efficacy and quality.
At CPDS, we understand the complexities of regulatory compliance. Our mission is to provide comprehensive support and guidance to help manufacturers navigate these requirements seamlessly. The 21 CFR Part 820 mandates a robust Quality Management System (QMS) integrating both drug and device components, ensuring a cohesive approach to quality assurance.
Incorporating LEAN principles into our approach, we focus on minimizing waste, optimizing processes and enhancing efficiency. By doing so, we ensure that your compliance efforts are not only effective but also cost-efficient and sustainable.
Our team is dedicated to helping you achieve compliance through our tailored services, including gap analysis, QMS updates and comprehensive training programs. Leveraging our expertise and the LEAN methodology ensures that your combination products meet the highest standards of quality and regulatory compliance while streamlining operations.
We are committed to supporting your journey towards excellence in quality management and regulatory adherence. Together, we can navigate the complexities of 21 CFR Part 820 and ensure your combination products’ success in the market.
Lean GMP for Pharma “Be the Best and Save Big” CPDS has developed a coherent system of methods, trainings and services for complex Pharma lean GMP systems (e.g. ISO 13485 + EU/US GMP).