MPE Systems





Complete Medical Device System Strategy

MANUFACTURING

MPE has invested in the manufacturing processes for the most expensive custom parts or critical quality components of the BOM

SUPPLY CHAIN

MPE has built out a global supply chain for commodities to complete medical device assembly

WAREHOUSING/3PL

MPE has created warehousing and 3PL model to deliver complete medical systems globally on time at lower cost

Supply Chain Solutions

  • Global Supply Chain Team: North America and Best Cost Country Sourcing Strategy
  • Supplier Quality Management Program including regulatory compliance and change control
  • Supplier Consolidation
  • Access to latest technologies
  • Product traceability ensure on-going regulatory compliance

Manufacturing Flow Line Benefits

  • Currently, 80% of the products we manufacture utilize one-piece flow assembly. This process allows the finished product to come off the line packaged, labeled and ready to ship.
  • Savings associated with medical device cosmetic expectations during final assembly
  • Product Validation and Test
  • With our one-piece flow process you can expect:
    • Savings associated with connecting final assembly with the highest cost BOM component processes.
    • Cost of quality savings mitigated via final assembly build validation.

ISO 5 Controlled Environment Cell

ISO 5 Cleanroom. ESD Safe. Temperature, Humidity, Luminex controlled

MPE’s authorized personnel and highly skilled assembly team manufacture specialty components and sub-assemblies critical to your architecture.

Our clean room
is capable of:

  • Temperature control
  • Humidity control
  • Air Filtration with Positive Room Pressure
  • Lighting @ 800-950 Lux
  • Restricting access to trained & authorized personnel
  • Unique material handling protocols
  • Application specific clothing & body covering

Electrostatic Discharge
(ESD) Safe

  • Compliant to ANSI S20.20 “Protection Of Electrical And Electronic Parts, Assemblies And Equipment”
  • ESD compliant packaging
  • De-ionizing equipment
  • Special Material Handling Equipment
  • Continuously monitored ESD workbenches

Clean
Environment

  • HEPA filtered, Laminar Flow assembly stations: ISO 14644-1, 2015E Class 5
  • Filtered, compressed, ionized air blow off guns: ISO 8537-1, 2010 Class 3 ISO S20.20
  • Standards validated through 3rd Party Auditing: Hi-Pot, ASTM, F24 particle, EN 12464, Luminance

Final Assembly Test Area includes

Hi Pot and Continuity testing

Pneumatic Testing

High & Low Pressure Gas Systems

OS, Firmware burn-in, S/W install

Application specific testing per customer request

Warehousing & 3PL

Flexible strategies drive product delivery solutions at lower cost. MPE can develop an inventory management program that fits your companies needs, whether it’s direct shipment to the end user or setting a min/max Kanban program.

MPE has invested in a new distribution center to manage finished medical device inventory and execute logistics strategies driving operational efficiencies:
  • Cost savings associated with avoiding intercompany transit costs
  • Savings configured to order at time of shipment
  • Savings attributed to order replenishment via Kanban pull order systems
  • Inventory carrying cost savings
  • Same day shipment benefits without associated excessive inventory costs
  • Lower regulatory risks with MPE 3PL tied to ISO 13485 certification
Our Systems
  • Custom Packaging Development
  • ISTA package testing
  • International Shipping
  • Customer Inventory Management
  • KANBAN programs
  • Warehouse and direct shipment to your customer

Contact us today to learn more about our Solutions and how we can make this happen for you.

  • Email Us
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