mds company profile

Medical Device Systems, LLCMedical Device Systems, LLC

Company ProfileCompany Profile

20092009

Medical Device Systems, LLCMedical Device Systems, LLC 22

Company Overview StatementCompany Overview Statement

MDS provides customers an avenue to not MDS provides customers an avenue to not only form a foundation in the North American only form a foundation in the North American and Pacific Rim markets, but to establish each and Pacific Rim markets, but to establish each customer as a trusted name and first choice in customer as a trusted name and first choice in their vertical. In addition, our Chinese their vertical. In addition, our Chinese medical device manufacturing capabilities medical device manufacturing capabilities allow us to pass on to customers substantial allow us to pass on to customers substantial savings through lower manufacturing costs.savings through lower manufacturing costs.

ServicesServicesPre Market ResearchPre Market Research To help manufacturers avoid large investment up front, MDS To help manufacturers avoid large investment up front, MDS

will conduct a thorough market analysis utilizing our will conduct a thorough market analysis utilizing our distribution throughout North America, Asia/Pacific and Greater distribution throughout North America, Asia/Pacific and Greater China.China.

Pre Market Regulatory ServicesPre Market Regulatory Services Through our office in Beijing, we provide full service Through our office in Beijing, we provide full service

consulting and management for obtaining SFDA and CCC consulting and management for obtaining SFDA and CCC approval for medical devices inside of China.approval for medical devices inside of China.

Through our pass-through regulatory partner in the United Through our pass-through regulatory partner in the United States, Reglera, Corp., MDS will help customers streamline States, Reglera, Corp., MDS will help customers streamline their regulatory issues quickly, efficiently and cost effectively.their regulatory issues quickly, efficiently and cost effectively.


Services continuedServices continued

Marketing of ProductMarketing of Product MDS will expose your product to a wide distribution and MDS will expose your product to a wide distribution and

dealer network while promoting your product thorough trade dealer network while promoting your product thorough trade shows, direct marketing, etc.shows, direct marketing, etc.

Building the Sales ChannelBuilding the Sales Channel Medical Device Systems can either build a distribution Medical Device Systems can either build a distribution

network either here in the United States or throughout network either here in the United States or throughout Asia/Pacific. We can also help your company hire a direct Asia/Pacific. We can also help your company hire a direct sales force.sales force.


Services continuedServices continued

Logistical ServicesLogistical Services MDS offers inventory management, import/export MDS offers inventory management, import/export

management, technical support, and spare part inventory as management, technical support, and spare part inventory as well as legal services through our US based law firm.well as legal services through our US based law firm.

Product LocalizationProduct Localization MDS has the unique ability to start you on the path to cost MDS has the unique ability to start you on the path to cost

savings through local product development, parts sourcing, savings through local product development, parts sourcing, and OEM/ODM services in China.and OEM/ODM services in China.


Customer TestimonialCustomer Testimonial Teknova Medical Systems was extremely pleased to choose Teknova Medical Systems was extremely pleased to choose

Medical Device Systems as our global regulatory and distribution Medical Device Systems as our global regulatory and distribution partner. The resources and professionalism that MDS brings to partner. The resources and professionalism that MDS brings to the table is unsurpassed. the table is unsurpassed.

We highly recommend Medical Device Systems to all companies We highly recommend Medical Device Systems to all companies looking to further their distribution network as well as companies looking to further their distribution network as well as companies needing a strategic manufacturing partner. needing a strategic manufacturing partner.

Anthony WuAnthony Wu

Chairman of the Board of DirectorsChairman of the Board of Directors

Teknova Medical Systems, Ltd.Teknova Medical Systems, Ltd.


General Description of our Chinese Manufacturing General Description of our Chinese Manufacturing Partner CompanyPartner Company

Manufacturing facilityManufacturing facility

Headquartered in Shanghai China, our manufacturing partner Headquartered in Shanghai China, our manufacturing partner was established in 1997. The company has over 160 was established in 1997. The company has over 160 employees and 5,000 square meters of production space and employees and 5,000 square meters of production space and more than 10 regional offices. It has become one of the best more than 10 regional offices. It has become one of the best design and manufacturing service providers of medical devices design and manufacturing service providers of medical devices in China. in China.

Production ServicesProduction Services


There are over 45 employees in the production department. There are over 45 employees in the production department. The production teams use cellular manufacturing techniques The production teams use cellular manufacturing techniques for productivity and quality improvement.for productivity and quality improvement.

The production services include:The production services include:

oMold makingMold makingoPlastic injectionPlastic injectionoPCB sub-assemblyPCB sub-assemblyoFinal assembly & calibration testFinal assembly & calibration testoFinished goods packagingFinished goods packagingoDeliveryDelivery

Engineering DepartmentEngineering Department


This department has six experienced engineers who all understand how to This department has six experienced engineers who all understand how to design medical products in a cost effective manner. They respect IP rights and design medical products in a cost effective manner. They respect IP rights and observe NDA obligations. They utilize turn-key services from Prototype observe NDA obligations. They utilize turn-key services from Prototype design to volume manufacturing to meet specific needs of the market. They design to volume manufacturing to meet specific needs of the market. They are devoted to helping our customers achieve excellent product performance are devoted to helping our customers achieve excellent product performance and quality to cope with up-to-date market demands.and quality to cope with up-to-date market demands.

They offer engineering services that include:They offer engineering services that include:

oMechanical DesignMechanical DesignoElectronic DesignElectronic DesignoTransducer DesignTransducer DesignoSoftware EngineeringSoftware EngineeringoProcess Engineering Process Engineering

Quality Control DepartmentQuality Control Department


The quality control department deploys Total Quality Management (TQM) The quality control department deploys Total Quality Management (TQM) methodology to produce superb quality products. They have invested in the methodology to produce superb quality products. They have invested in the highest quality precision manufacturing equipment.highest quality precision manufacturing equipment.

They have a zero field complaint status. They enforce GMP & ISO13485:2003 They have a zero field complaint status. They enforce GMP & ISO13485:2003 for medical products, and ISO9001:2000 and CE Mark for all products as well for medical products, and ISO9001:2000 and CE Mark for all products as well as FDA GMP 21CFR. They are able to design and manufacture medical as FDA GMP 21CFR. They are able to design and manufacture medical devices for the world-wide marketdevices for the world-wide market

CapabilitiesCapabilities


Their emphasis is on concurrent engineering with advanced computerized integrated Their emphasis is on concurrent engineering with advanced computerized integrated visualization of design construction using Rhino, CAD & CAM and other analysis to visualization of design construction using Rhino, CAD & CAM and other analysis to accomplish Rapid Prototyping. From concept to molding, they guarantee reliability accomplish Rapid Prototyping. From concept to molding, they guarantee reliability and cost effectiveness. Precision plastic injection machines are close-loop and and cost effectiveness. Precision plastic injection machines are close-loop and controlled by a computerized servo for multi-step injection and compression. They controlled by a computerized servo for multi-step injection and compression. They also supply casting, actuator (linear and rotary movement) and tolling management.also supply casting, actuator (linear and rotary movement) and tolling management.


Hardware EngineeringHardware Engineering

o Analog & Digital CircuitAnalog & Digital Circuito SensorSensoro PCB DesignPCB Designo Real time controlReal time controlo Power solutionsPower solutionso EMCEMCo Embedded micro-processor applications using Intel 8051 series or ARM seriesEmbedded micro-processor applications using Intel 8051 series or ARM serieso Data interfaceData interface


Software EngineeringSoftware Engineering

o GUIGUIo Windows applicationsWindows applicationso DatabaseDatabaseo Embedded micro-processor applications using Intel 8051 Embedded micro-processor applications using Intel 8051

series or ARM seriesseries or ARM serieso Our Central Monitor System contains a windows platform, Our Central Monitor System contains a windows platform,

VB, VC++, Database and other advanced techniques to VB, VC++, Database and other advanced techniques to assure the central monitor works more steadily ,more assure the central monitor works more steadily ,more efficiently, and achieves greater functionality. efficiently, and achieves greater functionality.

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