ZEISS CMM Validation Solutions for FDA Compliance

Written by Craig Borkowski

Last published at: July 12th, 2024

UPDATED July 2024:

This service is considered a standard training course, sold with new machines or by Aftermarket Sales. It was created by Carrie and Scott over 2 years as a solution to help Medical customers achieve FDA compliance in respect to their ZEISS CMMs.

Our largest Medical customers like Stryker, Zimmer, Medtronic will not be good fits.  They tend to already have Compliance departments and full processes. The best fit tend to be our new Medical customers who need to begin the process of obtaining compliance for their ZEISS CMM and related processes.

There are brochures / sales tools on the Z Drive under P67 Training.

There was a Feature Article in Quality Magazine back in June 0223 (link here):

 Medical | June 2023 | Quality (qualitymag.com)

 There are two parts to the complete product:

  • CMM Validation Solution for FDA Compliance is required for each customer 000000-2597-182
  • CMM OEM package for FDA Compliance is required for each CMM 000000-2597-180

The CMM Validation Solution for FDA Compliance is a week long process and  includes 6-8 hours of training and 4 days of guidance with the forms and documentation. The training is delivered virtually. Usually 2-3 people max from the customer would be involved. Once the customer has had this training they would be all set for future requirements and would not likely need another one.

For more information or support, please contact Scott Lowen scott.lowen@zeiss.com 248-924-7154 or Carrie Pfeifer carrie.pfeifer@zeiss.com 810 224-2447.