In medical device manufacturing, a minor deviation in equipment accuracy can lead to catastrophic product failures. Regulatory bodies demand documented proof that every machine, sensor, and process operates exactly as intended, consistently yielding safe products.
Qualitech International offers rigorous equipment calibration and full lifecycle process validation (IQ, OQ, PQ). We eliminate manufacturing uncertainties, ensuring your operations are flawless, audit-ready, and fully compliant with ISO 13485 and FDA 21 CFR Part 820.
Precision You Can Prove
We provide highly accurate calibration services and robust validation protocols to ensure your production environment never compromises product quality.
- Traceable calibration to international standards (ISO/IEC 17025).
- Comprehensive Equipment Qualification (IQ/OQ/PQ).
- Test Method Validation (TMV) and Gauge R&R.
- Cleanroom validation and environmental monitoring setups.
- Software validation for automated manufacturing systems.
What We Offer ?
High-precision calibration for temperature, pressure, humidity, flow, and dimensional measurement instruments, fully traceable to NIST/international standards.
We write and execute robust Installation, Operational, and Performance Qualification protocols for your manufacturing equipment and machinery.
Prove that your inspection and testing methods are accurate and repeatable through rigorous Gauge R&R (Repeatability and Reproducibility) studies.
Ensure that software used in your Quality Management System (QMS) or automated production lines functions reliably and meets FDA Part 11 requirements.
Comprehensive qualification of controlled environments, including HVAC systems, HEPA filter integrity, and particle count verification.
Establish documented evidence that your specialized manufacturing processes (e.g., sterilization, sealing, molding) consistently produce products meeting predetermined specifications.
Why Choose Qualitech International ?
On-Site Services
We minimize your production downtime by deploying our expert calibration technicians directly to your manufacturing facility.
Audit-Ready Documentation
We provide clear, comprehensive calibration certificates and validation reports that instantly satisfy auditors and Notified Bodies.
Traceable Accuracy
All our calibration reference standards are strictly maintained and traceable to national and international metrology institutes.
Frequently Asked Questions
Have questions about regulatory compliance, market access, or our services?
Here are answers to the most common inquiries from Medical Device and IVD manufacturers.
What is the difference between calibration and validation?
Calibration ensures an instrument measures accurately against a known standard. Validation is a broader process that proves an entire piece of equipment or a manufacturing process consistently performs its intended function.
How often should we calibrate our manufacturing equipment?
Calibration frequency depends on the instrument’s criticality, manufacturer recommendations, and historical drift data. Typically, it is performed annually, but critical sensors may require semi-annual or quarterly calibration.
Do you provide templates for IQ, OQ, and PQ?
Yes, we don’t just provide templates; our engineers can custom-write the specific IQ/OQ/PQ protocols for your unique equipment and execute them on-site.
