As a full service contract manufacturer, we produce an extensive variety of devices for healthcare, life science, dental, and diagnostic markets including billions of Finished Class 1 and Class 2 disposable medical parts. We offer Class 8 Clean Room molding and post molding services.
Quality Above All Else!
Our Quality Management System includes the following elements:
- Medical Device Culture designed around risk mitigation, PFMEA
- Quality team with extensive FDA audit/regulatory experience
- Workflow Diagrams/Process Mapping
- ISO 13485:2016, cGMP Compliant
- Process Capability Studies
- CpK, PpK, Tolerance intervals, GR&R
- APQP – Advanced Product Quality Planning
- FDA Registered
- Lean Six Sigma, DMAIC, 8D
- IQ, OQ, PQ Validation Processes
Our State-of-the-Art Medical Manufacturing Includes:
- Finished Class I and Class II Medical Devices
- Class 8 clean rooms
- Technology Transfers
- Climate Controlled Environment
- Value Add Assembly
- Commodity and engineered resins knowledge
- DFM – Design for Manufacturability
- Scientific Injection Molding including Level 3 Master Molders
- Tool Building
- Rotational Pad Printing
Current Medical Product Lines
- Patient care, drug delivery
- Syringes, catheters, wound care.
- Single use surgical instruments
- High volume diagnostic consumables
- Fully automated work cells
- Multi-tool surgical kits
- Laparoscopic procedures
- Cannulas, trocars, graspers, dissectors
- Packaged, sterilization ready
- Personnel Protective Equipment
As a medical molder for over 30 years, we understand the supplier partnership our customers need in order to provide the best quality products to your customers and patients while being cost effective and time sensitive. We are here to help you with that process.
See our case studies for some examples of customer solutions we have developed and launched.