Minneapolis-St Paul is one of the deepest medical device clusters in the country, and behind every device maker stands a network of contract manufacturers and precision shops. We write and prove out programs at your machine, ready for validation and built to the requirements of every customer you ship to.
The Twin Cities have been building medical devices since 1957, when the world's first wearable, battery-powered pacemaker was built in a Minneapolis garage. Today the region people call Medical Alley holds hundreds of medical device companies, from global device makers to startups.
The device makers set the bar for the whole industry. Around them works a deep supplier network: contract manufacturers, precision machine shops and component specialists from Plymouth and Maple Grove up through Anoka and Coon Rapids.
Many of those suppliers answer to several device makers at once, each with its own drawing conventions, characteristic numbering and report format. We build every program and report to the requirements of the customer the part ships to, and we support both sides: the quality labs inside the device makers, and the shops that make their parts. The CMM Programmer brings the same programming to either one.
In FDA-regulated manufacturing, a CMM program is treated as a test method, and the software behind it has to be validated for its intended use before the results count. Since February 2026, FDA's Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485, which requires software used for monitoring and measurement to be validated before initial use and revalidated, as appropriate, after changes.
We write programs with test method validation in mind: stable datum alignments, documented probing and fixturing, controlled revisions, and output built for gage R&R studies, correlation against calibrated parts, and whatever protocol your quality team runs. When the inspection report itself is an electronic record under 21 CFR Part 11, we work inside the approvals, signatures and record controls your system already has.
We do not certify programs or systems, and FDA does not certify CMMs or measurement software either. The validation decision stays with your quality system. What we deliver is a program that is ready to validate, and support while you validate it.
The work spreads across both cities and well beyond: the device corridor in the northwest suburbs through Plymouth, Maple Grove and Rogers, the north metro through Anoka, Coon Rapids and Blaine, the south metro around Burnsville and Shakopee, and east through St Paul to Woodbury. Wherever the machine is, we come to it.
Several shops in the metro with work waiting can share one visit and split the travel expenses between them. We work with you to make the most sense of your workload, schedule, and budget.
Maple Grove is also home to Zeiss's U.S. metrology business, and plenty of shops across the metro run Zeiss machines. For those shops, our Calypso offline programming writes programs without interrupting the machine.
New part programs written and proven out at the machine
An experienced contract programmer on your floor when the need arises, hourly or daily
First article dimensional reports built to satisfy your customer's quality requirements
Custom training on your parts, your probing, and your version
$125 per hour and $950 per day, the same rates as everywhere else in the country.
Yes, a CMM program can be validated for an FDA-regulated medical device process, and it usually has to be, because ISO 13485, now part of FDA's Quality Management System Regulation, requires measurement software to be validated before initial use, most commonly through test method validation, gage R&R studies and correlation against calibrated parts.
We write the program, prove it out at your machine, and support the validation runs and documentation during the visit. Where 21 CFR Part 11 covers your electronic inspection records, the program and its reports run inside the record controls your system already has.
Scheduling in the Twin Cities usually runs one to two weeks out for a planned multi-day visit, and sometimes sooner when the calendar allows, so a new product launch or a backlog of first articles is worth a call as soon as the dates are known.
Urgent situations get the same effort: we arrange travel around your dates the very best we can.
On-site programming coverage around Minneapolis and St Paul runs across the whole metro: the device corridor through Plymouth, Maple Grove and Rogers, the north metro through Anoka, Coon Rapids and Blaine, the south metro around Burnsville and Shakopee, and east through St Paul to Woodbury, with everything close enough to reach inside a single engagement.
Across the St Croix, Hudson and the Wisconsin side are in reach the same way. If the machine is anywhere in the Twin Cities, it's close enough.
Validation of a new CMM program for production inspection is always your decision and your record, because you own the quality system that defines what evidence is sufficient to release a program into regulated production use, and that judgment cannot be delegated to an outside programmer.
We prove out programs at the machine, and we can support first article runs, correlation checks and repeatability studies during the visit. But the final judgment that the program is fit to run production stays where your quality system puts it.
Tell us about the machine, the parts, and the timeline. We will do our very best to plan around your dates, and it costs nothing to talk through it first. When a quote is the next step, a follow-up comes back with timing and a straightforward number.
