MMEQ OEM by kbXo01

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									Modern Medical Equipment Manufacturing, LTD.

   Serving with Commitment & Excellence
     To the Medical Accessory Industry
                 Since 1988

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                       Contents
1.    Corporate
2.    Global
3.    Facilities
4.    Design & Engineering
5.    Project Management
6.    Manufacturing
7.    Quality
8.    Medical Fields
9.    Audit Approvals
10.   Financial
11.   MMEQ Charity Fund
12.   Conclusion

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                 Corporate Structure


                                 Modern Metal
                                    Group


Modern Metal        Modern Metal           Modern Metal           Modern Medical
Refining, Ltd.       Electric, Ltd.       & Industrial, Ltd     Equipment MFG, Ltd.
    1969                 1969                  1970                    1988
(Die-Casting)      (Silicon, Plastic)   (Technical Transfer)   (Surgical Accessories)




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                      Corporate History

1988 – Founded as Medical Device OEM Contract Manufacturer.

1996 – Expanded Business focus to include Private Labeling.

1998 – Expertise in knowledge and manufacturing grow to included
      Joint Product Development / Venture projects.

2000 – Established Dong Guan City manufacturing facility.

2007 – Established Qing Yuan manufacturing facility.




                                                                   4
Corporate Management




  Hong           China
  Kong
                         5
                       Global Operations

                                  Berlin, Germany
                                  Sales - Europe




Richmond, VA US
Sales – The Americas

                                                     Guang Dong, PRC
                                                     Manufacturing




                                                    Hong Kong
                                                    Headquarters


                                                                       6
                                      Factories
             MMEQ production facilities located in GuangDong Province, China




                QingYuan                                                 Dong Guan City
       Established: 2007                                                 Established: 2000
 Area: 60,000 Sq. Meters                                                 Area: 9,328 Sq. Meters
 Phase 1: 100 Employees                                                  Staff: 500 Employees
Phase 4: 2000 Employees
      (When completed)

                                                                               Hong Kong
                                                                               Established: 1988
                                                                               Staff: 50 Employees

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                        Design & Engineering
                 MMEQ onsite Engineering Department is equipped to develop
                   Your innovation from Concept to the Medical Market.

Capabilities:

 Design Analysis (Mfg / Testing / Assembly)
 Rapid Proto-Typing for Design Evaluation
 Material Selection
 Proto-Type Molds (Pilot Production & Design Verification)
 Biocompatibility Verification
 Failure Mode Effects Analysis (FEMA)
 Test Procedure Definition & Design
 Production Tool Design & Build
 Fixture Design & Fabrication
 Sterile Packaging Design                                    Supported Engineering Software:
 Product Verification & Validation                            AutoCAD
 Accelerated Aging Studies                                    Solid Works
 Sterilization Validation                                     Pro-Engineering
 Clinical Trial Builds                                        Acrobat Illustrator
 Regulatory Assistance                                        PhotoShop
                                                                                                8
                              Project Management

 The MMEQ Team is your resource for experienced TURN KEY Project Management.

(1) Feasibility Study:          (3) Engineering Samples:                   (5) Pre-Production:
• Project Requirements          • Mechanical Eng. Design                   • First Production Order Trial
• Project Objectives            • Rapid Proto-typing
• Define Marketing Specs        • Biocompatibility Verification
• Quotation & Contract          • FMEA Risk Assessment
• Milestone Planning            • Product Validation & Verification
                                • Project Procurement
                                                                         (6) Mass Production:
                                                                         • Focus – Efficiency, Quality,
                                                                                  Stability, & Minimize Waste
                                                                         • Lean Manufacturing
 (2) Design Concept:                                                     • Process Improvement
 • Organize Project Team          (4) Engineering Pilot:                 • Semi-Automation
 • Resource Planning              • Proto-type Mold Builds
 • Develop Project Schedule       • Tooling / Fixture Design & Build
 • Design for Mfg Analysis        • Sterile Package Design
                                  • Clinical Trial Builds
                                  • Test Procedure Definition & Design
                                  • Accelerated Aging Studies
                                  • Sterilization Validation
                                                                                                            9
                               Production
                     Component Part Manufacturing




                     PLASTIC                                             SILICONE
                     Molding in Certified 100K Clean Room.               Compression Molding
                      Injection Molding (Vertical & Horizontal)
                      Insert Molding
                      Over Molding
                      Transfer Molding
                      Blow Molding

                     CABLE                              METAL
                     Manufacturing in Certified         Precision metal part tolerance
                     Class 100K Clean Room.             Capable of less than 0.001”
                                                         Metal Injection Molding
                                                         Ceramic Injection Molding
     In-House                                            CNC Milling & Lathing
Tool & Repair Shop                                       Wire Cutting
                                                         Stamping
                                                         Electrical Discharge Machine         10
                            Production
MMEQ has complete control over component part production with the
In-House capability to perform a number of Secondary Operations.



       Electro-Polishing               Ultrasonic Welding
       Sand Blasting                   Laser Welding
       Passivation                     Laser Etching
       Heat Treatment                  Laser Marking
       Powder Coating                  Pad Printing
       PTFE Coating                    Custom Sintering
       TiN Coating                     Blister & Pouch Sealing




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                                  Assembly
   Product Assembly Operations Performed in Class 10K Clean Room




Monitored & Controlled

Temperature * Pressure * Humidity * Particle * Bio-Burden
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                                Quality Certifications
                                        Supported Registrations
     FDA Registered Manufacturing Facilities
Quality System Regulations:

ISO 9001:2008

ISO 13485:2003
(Medical Device Design & Mfg Std)


ISO 11137 Certified
(Gamma Ray Sterilization Method)

ISO 11135 Certified
(Ethylene Oxide Sterilization Method)

GMP – US

GMP - China
                                                                  13
                 Quality - Regulatory
                       Regulatory Support
MMEQ Regulatory Application Teams specialize in approvals for
Class I & II medical devices in the following domains:

          510 (K) for USA market
          CMDCAS for Canada market
          CE for Europe market
          SDA for China market
          MHLW for Japan market
          TGA for Australia market

Modern Medical has 23 years of
Experience in helping customers
Achieve market approvals for their
Surgical products.                                              14
                         Quality Procedures
                              Validation & Verification

Complete Product Documentation from Design to Sterilization.
      Device History Record
      Design Master Record
      Complete Device Manufacturing Process Documented
      In-Process and Final Quality Assurance
      100% Functional Inspection
      Full Lot Control for Tractability
Certificate of Conformance

Process & Equipment Validations including I/Q, O/Q, and P/Q.
      Protocol Development & Verification

4 Times Annually of Internal / External Audits.

Emergency Unit (EU)
                                                               15
                   Quality - Monitoring
              Reliability & Biological Laboratories

Modern Medical is dedicated to product and environmental testing to ensure
Adherence to standards, specifications and the highest quality of product.


                       Particle & Biological Clean Room conditions monitored.
                       Bio-Burden Level of Materials & Product Tested.
                       Product Performance Testing.
                       Product Aging Tests.
                       Failure Analysis.
                       Sterilization Dose Control.




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               Medical Market Fields
Modern Medical has developed expertise in providing disposable and
reusable surgical accessories for the following medical fields:


          Arthroscopy                    Oncology
          Cardiovascular                 Ophthalmology
          Electro-Surgery                Orthopedics
          General Surgery                Respiratory
          Laparoscopy                    Urology
          Neurology                      Wound Closure
          Ob / Gyn




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                   Audit Approvals

   MMEQ. facilities have been audited and approved by a number or
medical market leading companies and have been found to meet their
standards, practices, and procedures for medical device manufacturing.


  For references please submit Referral request to your local MMEQ
                           representative




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                               Financial

Financial Stability is essential in forming long term business partnerships.

MMEQ has…

 • Strong relationship with our Banks.
 • Excellent line of credit with customers to
   ensure healthy cash flows and effective
   working capitals.
 • Ability to support multiple currencies.
 • Fiscal Year from April 1 to March 31.




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Modern Medical Charity Fund

                 Since 1998, we have put
                  Our Beliefs into Action…

                     … It is better to Give
                      than Receive …

                 Donation of Capital Equipment,
                 Surgical Instruments, and
                 Medical Consumables.

                 Provide dental services and
                 Medical training to village doctors.

                 Provide services to special needs
                 Members of the community.

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                              Conclusion
Modern Medical Equipment Manufacturing, LTD has risen to be a
Global leader as an OEM medical device contract manufacturer of
Surgical accessories.

Let’s explore how MMEQ can support your business growth and success.


                    Questions & Discussion.


MMEQ Corporate Headquarters:          MMEQ US Sales:
5F Gold King Ind. Building,           1705 Dabney Road
35 Tai Lin Pai Road, Kwai Chung,      Richmond, VA 23230
N.T., Hong Kong
                                      Tel: (804) 353-7160 ext. 110
Tel: (852) 2420 9068                  Fax: (804) 353-7161
Fax: (852) 2481 1234                  David_Via@modernmedical.com.hk
mktg@modernmedical.com.hk
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