Engineering, Inspection & Validation Services
Reliable Testing Solutions to Ensure Medical Device Quality and Compliance
At Cretex Medical | QTS we offer comprehensive engineering validation, critical inspection, and in-house and contract laboratory testing services. We will 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.
Each stage of the lifecycle has its own requirements and considerations.
Comprehensive Validation Services
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.
Experts in:
- Installation Qualifications
- Operational Qualifications
- Performance Qualifications
Package & Seal Validations
Following ISO 11607 and ASTM standards, we provide rigorous testing to verify your packaging maintains its integrity and sterility throughout handling, distribution, and shelf life.
Our validation capabilities include:
- Seal validation protocol development (ISO 11607-2)
- In-house package integrity testing:
- Dye penetration (ASTM F1929)
- Bubble leak (ASTM F2096)
- Visual inspection (ASTM F1886)
- In house seal-strength testing
- Peel/tensile testing (ASTM F88)
- Burst testing (ASTM F2054)
- Shelf life & aging studies (ASTM F1980)
- Packaging system performance (transportation & distribution) testing (ISO 11607-1, ASTM D4169, ISTA 1-3 series)
Our teams are experts in packaging and testing specifications and standards that are complex and ever-evolving.
Cleaning Validations
- Our cleaning validation services ensure that your medical devices and components meet required cleanliness levels before assembly or packaging. We help confirm that your processes effectively remove residues, particulates, and microbial contaminants, supporting both product safety and regulatory compliance.
- Add additional details, ISO/ASTM info
- Aligned with ISO 19227 guidance
- Aligned with AAMI TIR30 guidance
- Add in passivation standards (but do not add to title of section)
Whether it’s guidance specific to reusable devices, implants, or instruments, we have the expert understanding.
Sterilization Validations
We support a wide range of sterilization methods and offer full validation services:
- EO, Gamma, E-beam, X-ray, and moist heat (steam) sterilization
- Add additional details, ISO/ASTM info
- Add additional details, ISO/ASTM info
- Protocol development & sample preparation
- Coordination of microbiological and analytical testing
- Detailed reporting
Our scientists closely monitor the evolution of sterilization technology and capacity so they can provide customers the most current advice.
Product Family Grouping
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.
Maximizing validation efficiency helps control costs and speed your products to patients.
Critical Inspection Services
Precision inspection is essential for product safety and regulatory acceptance. Our climate-controlled Class 8 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.
Our in-house services employ advanced technology to ensure quality, compliance and efficiency.
Contract Laboratory Testing Services
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?)
- Distribution and stability testing (add standards????)
Let us simplify your validation and ongoing lab testing needs and help you avoid the complexity of managing additional suppliers.
With our network of trusted suppliers, we can simplify bringing your products to patients.
Let’s Get Started
Whether you’re launching a new product or refining an existing one, QTS is your partner in validation, inspection, and testing.
Contact us to discuss your project.
