adminMedical Devices/Combination Products:
hartered Pharma Consultants provides a comprehensive range of services for all types of medical devices and combination products.
Regulatory Compliance for Medical Devices / Combination Products
Our consultants ensure that your products meet both local and international regulatory requirements, such as the Medical Device Regulation (MDR) in Europe and CFR Part 820, 210,211 in the US. We offer consulting services in various areas, including medical products, materials and components, processes and mechanical engineering, manufacturing, design history, as well as testing and validation.
Expert Quality Assurance for Medical Device and Combination Product Compliance
With over 40 years of experience, Chartered Pharma Consultants have worked with companies throughout the supply chain of Medical Devices and Combination Products. We specialize in reviewing facilities, equipment, quality management systems, computer systems, manufacturing and processes to ensure compliance with regulatory standards. We assist in the design and development of medical devices (Class I, II, and III) and combination products, ensuring that all processes are documented and meet the expectations of international regulatory bodies.
Engaging with Chartered Pharma Consultants gives you access to Quality Assurance consultants who have collaborated with leading organizations in the medical device and combination product sectors. Our deep understanding of industry regulations and requirements includes:
- FDA 21 CFR Part 820, 210, 211
- EU (MDR)
- UK (MDR)
- ISO 13485
- MDSAP
Manufacturers of medical devices and combination products rely on Chartered Pharma Consultants for solutions to automate operational and quality workflows, making it easier to prepare for and pass audits, and enhancing productivity with available resources. We have extensive experience in designing and developing ISO 13485 compliant quality systems and conducting audits of facilities that develop hardware and software impacting overall product quality.
Training for Medical Devices / Combination Products
We offer training for medical device manufacturers, both in classrooms and online, on relevant topics in quality management and manufacturing.