Medfab Precision Solutions:
Gage R&R
When precision is critical, as in medical manufacturing and other tight-tolerance sectors, it is essential to measure the parts produced to confirm their conformance to specifications. Even more important to ascertain the precision of the instruments and systems used to make those measurements. This is called Gage Repeatability and Reproducibility (Gage R&R), and it is an integral part of our quality assurance process at MedFab.
Aiming for Perfection at MedFab
In the ultra-high-precision world of medical manufacturing, consistency and repeatability are everything. Inaccuracies can lead to irregularities, which can have dire consequences. The most stringent quality control measures must be followed. An ISO 13485:2016-certified company, MedFab takes every step to confirm the precision of its output. With Gage R&R, we are able to:
- Confirm the reliability of our measuring systems.
- Identify and reduce variations in the verification of critical components.
- Support regulatory and industry compliance through rigorous quality control.
- Minimize the occurrence of defective products reaching the consumer.
Our Distinctive Approach to Gage R&R
At MedFab, Gage R&R isn’t a standalone process; we integrate it throughout our quality assurance program to enhance the reliability of other important processes, such as:
- First Article Inspection – Read More
- Capability Studies – Read More
- Production Part Approval Process (PPAP) – Read More
- Failure Modes and Effects Analysis (FMEA) – Read More
Our in-depth analysis of both repeatability (the degree of variation in the output of a single operator) and reproducibility (the degree of variation in the output of multiple operators and instruments) ensures that our measurement systems provide highly accurate data for every part and component we make.
Gage R&R Benefits for Medical Device Manufacturers
With MedFab as your manufacturing partner, you can rest assured that your parts and components confer the benefits of our methods and precision, including:
- Exceptionally consistent part accuracy.
- Total compliance with FDA and ISO 13485 standards.
- Lower risk of rework, scrap, and delays that can arise from measuring errors.
- Data-driven validation of measurement systems for complete trust in quality control.
Commitment to Precision and Compliance
At MedFab, precision isn’t just our middle name–it’s why we’re here. Our continual investment in updating and upgrading our quality control measures keeps MedFab at the top of our game by allowing us to produce critical mechanical parts to the absolute highest degree of perfection technology can achieve.
Gage R&R is just one tool in our QC tool belt.
Get in touch today to find out more about the lengths we go to get it right every time.