Design for manufactureability,
safety and reliability

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ODM Manufacturing

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Mantra Sports
 

 

 

We specialize in ODM manufacturing of Health Care products including TENS, Stimulators and hand held electronic devices..

We are also able to take on many types of manufacturing concepts using chip on board technology.

We are actively looking for distributors for Mantra products in the USA, South America and Asia.

Our partner company Verity Medical Ltd. www.veritymedical.co.uk is actively looking for distributors in Europe.

Design, Manufacture and Distribute !

 

 

Engineering development & QC team

 

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OEM Branding

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We have developed a significant market presence both in the USA and Europe supplying major distributors with various custom manufactured products.

We have developed many types of 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 the power to create and we are able to manufacture a vast and diverse array of products. If your company is looking for a reliable and low cost firm,contact us for a quote.

Production

 

 

   
 

Creative Design

Our team is equipped with the latest Computer Aided Design (CAD) product development tools to bring your product ideas from conception into a twenty first century, world class, product that not only looks superb but also functions perfectly and will go on functioning perfectly for many years to come.

 

 

   

Design for Manufactureability, 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 control knobs and all other internal components, meet all our stringent requirements, a detailed Technical File for our customers approval is made. It contains:-

1. Functional specification
2. A complete set of all the drawings
3. Parts list
4. Schematics
5. Manuals and labeling
6. List of applicable regulatory standards such as, for example ISO13485, EN60601-1, IEC801 etc
7. Risk Analysis : EN ISO 14971-2000, EN1441 etc
8. Failure mode and effect analysis (FMEA)
9. 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.

SMT Oven

Machine Shop

 

 

   
Machine Shop

Unit Cost and minimum orders required

During the whole process described above, we endeavor 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 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.

For custom labeling, of our TENS unit the minimum order is 500 units per shipment. Please click here for OEM branding information.

 

 

   

Please Contact us for more information about our ODM services

 

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TENS - Inside Circuit board
 
   
 

 


ISO9001:2000 ISO 9001 ISO 13485 ISO13485:2003

All our products are manufactured in compliance with the Medical Device Directive MDD93/42/EEC under the supervision of SGS, Notified Body number 0120.