Process Validation

We handle process validation with the rigor and competence of a company exclusively focused on medical device manufacturing. That’s one less thing for you to be concerned about—and more freedom to focus on growing your business.

Donatelle’s manufacturing process validation is compliant with Quality System Regulation 21 CFR Part 820. Our technical experts are experienced in medical device process validation methodologies, validation sampling techniques, Geometric Dimensioning and Tolerancing (GD&T), scientific process development and sterilization management. Team members include Certified Packaging Professionals (CPP) with sterilization process expertise to help with developing your packaging concepts, Certified Quality Engineers (CQE) and manufacturing process-specific experts.

We offer:

  • Complete process documentation
  • Decisions based on statistical evidence and risk assessment
  • Confidence in manufacturing processes through scientific methods
  • Quality built in upfront, not inspected in after the fact
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