Mantra International Ltd - OEM and ODM manufacturing of health care products

ODM Manufacturing

We specialize in ODM manufacturing of a wide range of Health Care products including TENS, Stimulators and hand held electronic devices. We are able to take on many types of manufacturing concepts using various types of different technology.

Engineering development, Manufacturing & Quality Control

We have developed a significant market presence both in the USA and Europe supplying major distributors with various custom manufactured products for specific areas in the health care and other industries alike.

Our strong technological foundation enables us to easily bring new products from the creative design stage right through to mass production. Our International Engineering design team has already developed adaptable operating systems for a variety of sophisticated micro controllers. We have a stringent internal quality control and we strictly comply with ISO, FDA regulations and customer requirements / documentation.

Creative Design

Our creative and dedicated team is equipped with the latest Computer Aided Design (CAD) product development tools to bring your ideas from conception into world class products with a superb look and excellent function and reliability.

Design for manufacturability, safety and reliability

From the outset, we carefully consider all aspects of the function, performance, reliability, possible failure modes and product safety. A detailed quality plan is prepared and when the proposed design including the cabinet, PCB, display (usually custom LCD), key pad and/or controls and all other internal components, meet all our stringent requirements, a detailed Technical File for our customer’s approval is made. It contains:-

• Functional specification
• A complete set of all the drawings
• Parts list
• Schematics
• Manuals and labeling
• List of applicable regulatory standards such as, ISO13485, EN60601-1, 60601-1-2 etc
• Risk Analysis: EN ISO 14971
• Failure mode and effect analysis (FMEA)
• Analysis of compliance with all the applicable standards

A detailed project plan is prepared to guide the project through all the stages of tooling preparation, first samples, QC testing and exhaustive firmware validation. At this stage we also carry out our severe (extreme) use tests to verify our estimates of the expected product life and help to expose any design weaknesses. Following customer's approval the new product is then ready for its first pilot production run and, after validation, for mass production.

During the whole process described above, we endeavour to draw from our large experience of material and component sourcing and to design a product to achieve the lowest possible unit cost while in no way compromising quality, clinical reliability and expected product life. (Note: our key pads are designed to last to at least one million operations). Because we are vertically integrated, our non-recurring Engineering Development and tooling cost is astonishingly low. We have a high volume production facility.