Medical Device Process Validation Services

BMP Medical offers full medical device process validation services for all of our customers. We will work individually with a project manager and your team to develop a validation master plan for your project. The plan can range from simple go/no go to a full IQ/OQ/PQ protocol. We customize the plan based on the customer’s needs and requirements. Many of our customers require full statistical data analysis for their project, and we use the latest software to provide cPk and pPk. We also use an automated vision system to measure parts and can provide gage R&R testing as part of the validation. When necessary, BMP Medical partners with several metrology houses for high volume measurements, or for measurements that are beyond our internal capabilities. The following list is a snapshot of some of the validation products and services:

  • Validation Master Plan
  • IQ, OQ and PQ Protocol
  • Data Analysis with Minitab Statistical Software
  • FMEA Process
  • Keyence Vision System
  • First Article Samples