Product Development and Full Service Contract Manufacturing for the Medical Device Industry

Con-Tech Plastics has been providing precision injection molded plastic parts and assemblies to the medical device industry for over 25 years.  We offer an impressive range of capabilities for clean-room injection molding, mold manufacturing, design engineering, process validation, assembly and packaging.  Our team of cross functional engineers and regulatory affairs associates understand the stringent QA and Regulatory side of medical device manufacturing.  We can provide the expertise and support needed for design, tooling, and process validations.  

Our ISO 8, temperature controlled medical clean-room is equipped with :

• State of the Art Injection Molding Machines with barrier walls to isolate de-molding zones from raw material handling and heater zones.
• All Electric injection molding with Statistical Process Controls.
• Isolated De-Ionized air zones for de-molding or secondary operations.
• Dedicated auxiliary equipment for Complex Assembly, Testing, and Packaging Requirements.
• State of the Art Sonic Welding,  up to 2200 watts of power.   Capable of welding in three unique modes.  Standard Time mode and distance welding in either collapse or absolute modes with limits.  
• Inspection and test instruments for process validation.  Including Compression Force and Air Flow Measurement Devices. 
• Heat Sealing and Pouch Sealing Equipment.
• Our class 100,000 clean-room is ideal for product development and validation.
• For Clean-Room requirements of ISO 6 or better, modular containment areas can be added per customer needs.

Providing Medical Manufacturing Expertise :

• Total Program Management.  A single point of contact Project Engineer will coordinate all cross functional engineers to determine product specifications and performance.
• We understand the stringent quality and regulatory requirements of the medical device industry.  Our ISO 9001 quality management system has adopted process validation procedures and protocols compliant with ISO 13485 and GHTF/SG3/N99-10:2004 ( Edition 2 )
• Product Design and Engineering- Design for Manufacturability and Assembly
• Expert Design Evaluations.
• Engineering of Assembly, Testing, and Packaging requirements.
• Process Validations
• Supply Chain Management

Product Development, Prototypes, and Mold Manufacturing.

• In-House Tool Room and Machining.
• 3D CAD Modeling with SLA, SLN, and Machined prototypes.
• Detailed Part and Mold Design with Mold Flow Analysis.
• Fabrication of simple to complex multi-cavity molds – SPI Class 101 to SPI class 103 type molds.
• Aluminum Prototype molds
• Design and Fabrication of jigs, test, and assembly fixtures.

Additional Capabilities : 

• Over- Molding- Insert Molding
• Structural Foam Molding
• Precision Custom Plastic Injection Molding Parts from 1 gram to 9 lbs.
• Simple to complex Mold Coining
• High speed Hot Stamping
• Silk Screening
• Painting-EMI Shielding