MedTech | 50 employees | Germany
A MedTech company introduced a new phase laser for marking surgical instruments in a highly regulated environment. The goal was to achieve regulatory confidence and make the laser marking process stable, robust, and truly controllable in the long term.
Challenge
– Revalidation of a quality-critical laser marking process
– Multiple stainless steel materials with different surface finishes
– High regulatory requirements from FDA 21 CFR 820, MDR (Class I & II), as well as ISO 13485 and ISO 14971
A familiar situation for many MedTech teams: high complexity, little tolerance for deviation, and a process that must withstand audits at any time.
Approach
– Complete IQ, OQ, and PQ validation of the new phase laser
– Cross-material worst-case strategy with clearly defined parameter windows per material
– Risk-based FMEA in accordance with ISO 14971
– Extensive stress testing, including corrosion, wash-out, and passivation tests over multiple cycles
– AI-supported assistance for structuring and ensuring consistency of the documentation
(technical assessment, decisions, and approvals remained fully with the human experts)
The focus was not just on formal compliance, but on making the process genuinely usable in day-to-day operations.
Results
– 0 findings in internal reviews and regulatory assessments
– Process release for serial production
– Approximately 2× faster introduction of new laser markings
– Clear parameter windows and worst-case limits enable new variants without recurring fundamental discussions
Your next step
Are you facing a (re)validation of a laser or manufacturing process in a regulated environment?
Or do you want to make existing processes audit-safe without adding unnecessary complexity?
Let’s talk.
In a short conversation, we’ll identify your key risks and discuss how to validate processes that pass audits and work in real life.