Process Development and Validation

Medical Device Manufacturing (MDM) has worked with over 250 medical device companies and is experienced in evaluating your project, fine tuning the development steps and validating a repeatable manufacturing process.

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

At MDM, we will do the following:

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

MDM’s focus is to create and maintain high levels of Process Repeatability and Process Capability (CpK). Optimizing the process such that output values fall well within the prescribed specification range ensures that both product and process are robust. This in-turn leads to reduced costs in terms of waste (scrap and labor), resulting in higher yield of qualified products and reduced cycle times.

  • Ongoing Cost Savings
  • Material and Labor Savings (waste elimination)
  • Yield Improvement
  • Cycle Time reduction