Validated Processes

FMI Medical has validated cleaning and passivation processes that adhere to 21 CFR Part 820.75 and ISO13485:2003 section 7.5.2 requirements.  FMI performs installation, operation, and performance qualifications for all of our validated processes.  We also work closely with our customers to meet their testing requirements for particulate count, total organic carbon (TOC), cytotoxicity, pyrogen and bioburden.

A Closer Inspection

The FMI inspection department uses the highest standards and is equipped with state-of-the art equipment.  All inspections are performed with certified and calibrated test equipment.

Standards

The quality assurance and inspection standards to which we adhere:

• ISO13485:2003
• ISO9001:2000
• CGMP (21CFR 820)
• C=0 Sampling Plan

Calibration Systems

The calibration systems used to calibrate our quality assurance and inspection tools are as follows:

• Mil-Std-45662
• ANSI-Z540.1

Instrumentation

FMI has advanced inspection instrumentation, including coordinate measuring machine and vision system.  Examples of our inspection instrumentation are detailed below:

Renishaw CNC Machine Tool touch probe

Model: MP12 Compact Inspection Probe
Travel: 44" x 20" x 20"
Repeatability = 0.0004"

Brown & Sharpe - Global Advantage 575 CMM

Model: 575
 

Brown & Sharpe - TESAVision 300 DCC

Model: 300 DCC

Other Equipment

Starret Surface Plate
Grade: A
Surface: 4' x 6' x 8"

Master View Optical Comparator
Model: 2000
Travel 6" x 19"

Fowler Trimos 600+ Digital Height Gage

Mark-10 Torque and Compression Gage

Starret Analog Hardness Tester