Quality Management System

We, at Biotech Orthomed, have set up a well-equipped Quality Management System (QMS), which is designed to fulfil specific requirements of testing and quality checking of medical devises, and delivering reliable results. From controlling quality to final inspection, Biotech makes sure that the medical device manufactured at our facility is traceable and tested.

Ours is an ISO 13485 certified organization that is known to abide by the best regulatory standards (ISO, FDA, CE). Biotech works exclusively with certified partners and suppliers. Besides this, our processes are designed to test product’s entire lifecycle as well as its logistic conditions.

Our Quality Management System is also audited every year. Bureau Veritas, an independent certification body, verifies our system for conforming to international standards, regulatory needs, and ISO norms. It allows us to deliver safe and tested products in the market.

Our quality policy allows us to meet our objectives by focusing upon core points like:

• Abidance with best international manufacturing practices, standards, and regulatory requirements.
• Regular customer follow-ups and ensuring satisfaction.
• Time-to-time trainings of employees.
• Reliability and availability of appropriate resources.

These key points have helped us achieve quality certificates like CE, ISO 9001, ISO 13485:2016, WHO-GMP, and USFDA.