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Contract Cleanroom Assembly and Packaging

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Phone : (714) 694-0348
E-mail : Info@SpecialTeam.com

An ISO and FDA Registered Facility: ISO 13485:2003 | FDA Registered 2032092

Process Development

Process Development

SpecialTeam has worked with dozens of medical device companies and is experienced in evaluating your project, fine tuning the development steps and validating a repeatable manufacturing process.

We welcome start-up projects. Building a business relationship with small start-up companies affords our clients the ability to focus on marketing and sales while leaving the manufacturing to us. In addition, our five certified Class 1,000 (ISO Class 6) cleanroom suites and experienced staff are also ready to assist with your stressful over-flow production demands!

Full traceability of all phases of assembly/packaging is maintained with complete client communication during the production run. After the product is shipped, a follow up call is initiated to ensure that the client is completely satisfied with the services we have agreed to provide.

All processes within the medical device manufacturing arena require a careful process development plan.

At SpecialTeam, we will do the following:

  • Develop and write manufacturing instructions (if needed)
  • Create the in process testing protocol (if needed)
  • Design and fabricate fixtures
  • Suggest process improvements
  • Perform IQ and OQ on all products and equipment
  • Confirm Design and Experiment (DOE)
  • Perform the Process Qualification (PQ)
  • Utilize FMEA to ensure regulatory compliance
  • Generate a well documented final report

SpecialTeam's focus is to create and maintain high levels of Process Repeatability and Process Capability (CpK). Optimizing the process results in:

  • Ongoing Cost Savings
  • Material and Labor Savings
  • Yield Improvement
  • Cycle Time Reduction

The special relationships we have forged with our customers have been the foundation for SpecialTeam and its growth. Our 18 years of experience gives us the ability to efficiently manage our resources and get your product to you quickly without compromising quality.

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