Production processes for medical devices such as syringes benefits from process monitoring for highest quality.

Medtech

Quality assurance – producing medical devices in compliance with FDA and MDR regulations

Are you interested in achieving zero-defect production, 100 percent process transparency and enhanced process stability through automated monitoring of process limits? Are you aiming for product traceability with reduced outlay on documentation in your manufacturing facility?

In compliance with FDA and MDR requirements for quality assurance in medical device manufacturing, Kistler offers support and solutions that meet the very highest technical standards:

Modular process monitoring systems in the ComoNeo and maXYmos product families, tailored to your specific needs in injection molding, assembly and product testing
maXYmos TL ML, the world's first FDA- and MDR-compliant process monitoring system
A complete solution for electromechanical NC joining systems (servo press)
Miniaturized pressure, force and torque sensors for every application

Play safe with Kistler, your partner for medical device manufacturing. Our application-specific know-how and proven solutions for production, product assembly and testing will help you to combine consistent quality and maximum safety with cost-effective operation.

We will efficiently support you in achieving a MDR and FDA compliant quality assurance for medical device manufacturing and production of pharmaceutical products.
Just contact us.

Process monitoring systems from Kistler for medical device manufacturing (assembly and testing) enhance the transparency and traceability, improving overall product quality and product safety. Our solutions facilitate efficient quality assurance by enabling production in compliance with FDA and MDR regulations.