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Medical Device Regulatory

The medical device manufacturing sector is one of the most regulated sectors in which significant-quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place medical devices that are safe and suitable for their intended use onto the market.

TQM’s Involvement in ISO 13485 Medical Devices Quality Management System

Early in 1999, TQM received funding from the HKSAR Government to assist practitioners in the medical equipment industry to establish ISO 13485 MD-QMS (called EN 46000 at the time), ISO 9001 QMS and CE Marking to enter the European Market. TQM, in collaboration with IIE (HK), is the first private organization to receive the Industrial Support Fund of the HKSAR Government for a “CE Marking and EN46000 Project” for medical devices manufacturers.

Through this project, TQM helps manufacturers to meet the requirements of EU importers, fulfils the requirements of CE & EN 46000, and obtains the marking and certification. (Note: CE Marking is the threshold for manufacturers of medical devices to enter EU market; EN 46000 is the quality management systems for medical devices in accordance with certain specific requirements)

With our exceptional real industry experience, TQM has been providing professional support to dozens of companies in obtaining ISO 13485 MD-QMS/ FDA/ ISO 9001 QMS/ CE Marking, including Emerson, Ewig, Item, Fuji Dynamics, Modern Medical Equipment, Filligent, GE, Jacobson Medical, Perfect Ceramic Dental, Well Dental Laboratory, Golden Horse Medical Equipment, Plenty Source, Eagletron Telecommunications, Wai Tat, Season, Wing Hing, etc.

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ISO 13485 Medical Device Quality Management System for

Intramedullary Nail Manufacturer

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