medical device product development process

Process validation

Be confident in your program results

Before you can bring a critical medical device to market to help enhance – and save – lives, you need to be certain it’s right and ready. Along with a commitment to absolute quality standards, our medical device contract manufacturing offers rigorous process validation.

We are:

  • FDA registered as a contract manufacturer
  • 21 CFR 820 compliant
  • ISO 9001 and ISO 13485 certified
  • Proficient in Class I, II and III devices
  • Good Manufacturing Practice (GMP) compliant
  • Global Harmonization Task Force (GHTF) practitioners

Using empirical data to understand and control all sources of variation that can affect product quality, our medical device contract manufacturing team proves out and provides documented evidence your product will meet specifications and quality attributes. And we provide all the documentation needed for your design and device history files, and device master record.

Our highly qualified team of specialists includes certified packaging professionals and quality engineers. They are experienced in medical device process validation methodologies, validation sampling techniques, Geometric Dimensioning and Tolerancing (GD&T), scientific process development and sterilization management.

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