Engineering, Inspection & Validation Services

At Cretex Medical | QTS we offer comprehensive engineering validation, critical inspection, as well as in-house and contract laboratory testing services to help you meet the strictest quality, safety, and regulatory standards for your medical devices. From packaging and sterilization validations to advanced inspection techniques, our team supports every phase of your product lifecycle.

Ensuring your medical device packaging and sterilization processes are reliable and compliant is at the core of our validation services. We specialize in executing IQ/OQ/PQ protocols for package seal integrity testing, sterilization validation, and validated cleaning processes in ISO-classified environments. Our quality and engineering teams collaborate with you to ensure every validation is documented and aligned with current regulatory and industry standards.

Optimize your validation strategy and reduce overall costs by leveraging product family groupings. Our team works closely with you to define logical groupings of similar products, enabling you to validate more efficiently without compromising compliance or quality. We can assist you with:

• Developing and justifying product family logic based on risk, design, and material similarities
• Selecting appropriate representative samples for testing
• Applying family grouping strategies for:
  • Packaging validations
  • Cleaning validations
  • Sterilization (EO, radiation) validations

This strategic approach reduces the number of required validations, shortens timelines, and ensures full alignment with regulatory expectations.

Precision inspection is essential for product safety and regulatory acceptance. Our climate-controlled inspection suite and certified inspection team are equipped with advanced tools to ensure products meet your quality specifications.

Key Capabilities & Equipment:

• SmartScope® 3D vision system
• SmartProfile software for complex GD&T analysis
• Digital calipers, micrometers, pressure and force gages
• Optical comparators, microscopes, surface inspection tools, thread/pin/ring gages, and more

Specialized Services:

• Custom, ASQ, and ANSI sampling plans (Z1.4, Z1.9, C=0 Squeglia)
• Gage R&R (Repeatability & Reproducibility)
• Custom gage and fixture design

Staff Certifications:

• Certified Quality Engineers (CQE)
• Certified Quality Auditor (CQA)
• Certified Quality Technician (CQT)
• Certified Packaging Professional (CPP)
• Certified Lean Leaders and Practitioners
• Sterilization/microbiology certs?
• Sterilization/microbiology certs?
• Sterilization/microbiology certs?

We serve as your dedicated inspection partner, offering final component inspections independent of upstream suppliers, without the added complexity, cost, or lead time of coordinating with a third-party lab. Our in-house services support both ongoing quality monitoring and initial component qualifications as part of your New Product Introduction (NPI) process, eliminating the need to maintain your own inspection lab.

Through long-term partnerships with accredited ISO/IEC 17025 labs, we provide coordinated contract testing with seamless support from our certified microbiologists.

Available testing services include: 

• Bioburden enumeration and identification (add standards?)
• Product and BI sterility testing (add standards?)
• EO residuals (add standards?)
• Endotoxin (pyrogen) testing (add standards?)
• Cytotoxicity testing (add standards?)
• Gravimetric analysis for evaluation of product cleanliness (add standards?)

Let us simplify your validation and ongoing lab testing needs and help you avoid the complexity of managing additional vendors.