02/09/2024
Fameux Madical LLP is proud to announce the successful completion of a turnkey project in North Gujarat, with Manufacturing license as per MDR 2017 & ISO 13485 Certification.
We transformed an old medical disposables facility (producing surgical gowns, surgical drapes, medical accessories, and surgical packs) into a state-of-the-art medical device facility with minimal expense.
Our approach focused on leveraging all existing resources. Fameux Medical provided complete guidance throughout the project, including plant layout design and documentation as per MDR 2017 requirements to secure the manufacturing license. We also ensured ISO 13485 QMS Certification through effective implementation, comprehensive training, and personnel development.
Key areas of support included:
Process flow management
Design, development, and manufacturing processes
Material management and supply chain optimization
Human resource management
Engineering and process validation
Development of an in-house testing lab
Risk assessment, stability studies, and in-house validation
External testing to meet international and national standards
Customer-related processes
Self-inspection and data analysis
Consulting Services by Fameux Medical
At Fameux Medical LLP, we specialize in consultation services for facility upgradation, modification, and new projects within the medical device, in-vitro diagnostics (IVD), and primary packaging industries. Our expertise spans quality management, certification, regulatory compliance, and training. We offer end-to-end services, from product development to certification and compliance.
Learn More
For a detailed overview of our services and how Fameux Medical LLP can contribute to your projects, please visit our website: www.fameuxmedical.in
Contact Us:
If you would like to learn more or schedule a consultation, please feel free to contact us: Pravin Bhadsale Dhaval Shah