Donatelle’s medical 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.

From our process validation you can expect:

• 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
• Reduced time to market

When it comes to process validation, you can trust Donatelle. Our extensive experience and capability in this area allows you to focus on what’s most important to you: growing your business and product design and development.