We build, fix, or operate quality management systems (QMS) for medical device companies, scaled to the size of the company and not over-engineered.
Systems that were right for a 20-person company often fail at 200. Procedures multiply, ownership blurs, and records lag the work. We reshape the system around how your company runs now.
If you are moving to an electronic quality management system (eQMS), the way the system is organized matters more than the software. A wrong structure carried into a new tool is expensive to undo, so we design how it is organized first.
We can also operate the system for you while you hire, so quality does not stall.
When to call us
- “Our quality system was built for 20 people and we are now 200.”
- “We are migrating to an eQMS and the structure is wrong.”