We have a state-of-art manufacturing facility located in Bangalore, Karnataka, India; meeting ISO 13485 Quality Management system with Class 10,000 clean room systems and GMP (as per schedule M). The production process is carried out in a controlled environment to the highest consistency, with traceability and documentation as per the standard regulatory guidelines.

Fibroheal endeavor to achieve global standards in manufacturing. Stringent in-process quality control checks are maintained at every stage of the manufacturing process to maintain the quality & safety of manufactured products (i.e both medical devices and other wound care products). Through an internationally certified quality management system, clinical surveys and case studies, we optimize our products, treatment approach and concepts on an ongoing basis.

Quality Assessment & Quality Control

We always strive to improve our quality; so, our focus is constantly on quality control and assurance. We have a very strong QA and QC team, dedicated to maintain and improve the quality of our products and set new benchmarks using the latest technologies.

Each production line is supervised by a dedicated QA executive who vigilantly monitors all production activities as well as coordinates with the QC and production team to ensure that quality standards are implemented, followed as per GMP and standard regulatory guidelines.

We use automated machines in our plant, including sophisticated instruments such as HPLC, AAS, FTIR, Stability chamber and more, which are used at every stage of the manufacturing process, including analyzing RM and PM, in-process samples and finished products.

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