ISO Certification
With our ISO 13485:2016-certified QMS, MedFab promises high-quality manufacturing while actively pursuing continuous improvement and remaining focused on customer satisfaction. We achieve this through a comprehensive quality assurance program consisting of multiple initiatives at every stage of design and production.
With a lower-than-industry-standard escape rate, MedFab is known for the dependability and consistency of its output. To that end, we employ a host of technologically advanced tools to help us maintain this impressive performance, including, but not limited to:
- RAM Optical Vision Systems
- OGP Sprint MVP Vision Systems
- Manual & Programmable CMM machines – Brown & Sharpe
- Zeiss Profilometer
- Keyence Image Dimension Measurement System
- Various surface plates and precision hand-held metrology equipment
Quality Assurance Services
MedFab’s robust quality Assurance program includes a full range of industry-standard initiatives, including:
Capability Studies
Medical devices require extreme accuracy, often down to microns, to ensure proper function and biocompatibility. Using statistical analyses of the process capability index (Cp) and the process capability ratio (Cpk), MedFab can assess the performance of its manufacturing processes at any time, determining the stability, repeatability, and ability of that process for producing parts that meet the specifications of the customer.
First Article Inspections (FAI)
FAI is a comprehensive evaluation of the first produced component in a manufacturing run. This process verifies that the initial part meets all design, material, and dimensional requirements. MedFab conducts FAI according to AS9102 standards, ensuring a detailed, structured review that minimizes errors and enhances repeatability.
Gage R&R
When precision is critical, as it is 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, however, is the process of ascertaining 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.
Production Part Approval Process (PPAP)
PPAP is a key procedure used by several industries to ensure that manufactured parts meet quality and industry requirements and to minimize the risk of potential challenges in the future. With 18 separate elements, PPAP lays out clear guidelines for suppliers like MedFab, letting us know what our customers expect from each part.
Failure Mode and Effect Analysis (FMEA)
FMEA is a popular tool used across many industries to proactively identify and address potential risks within a chosen process–in our case, a particular manufacturing process. The analysis provides a deeper understanding of risks and encourages planning for any potential problems.
Statistical Process Control (SPC)
Statistical Process Control is all about consistency. Using statistical data collected by continuously monitoring production processes, SPC lets MedFab technicians identify production and performance anomalies in real-time, highlighting issues at the outset, often before they can adversely affect quality.
Advanced Product Quality Planning (APQP)
APQP is a popular tool used in industries with complex products and supply chains, where the risks of failure multiply as complexity increases. Though it has existed in many forms for several decades, the core tools of APQP today allow manufacturers like MedFab to maintain compliance with IATF 16949.
Put Our Process Engineering Expertise to Work
Medfab’s process engineering expertise is the key to unlocking efficiency and quality in manufacturing. If your operation needs streamlining, cost-cutting, or a complete overhaul, Medfab engineers are ready to jump in.
For More Information on Quality at MedFab, Contact Us Today