Kistler supports you as your partner in every phase of quality assurance for manufacturing medtech devices.

Quality assurance in medtech manufacturing – innovative sensor technology for every phase

Manufacturers of medtech devices as well as plant manufacturers operating in environments where medtech equipment and pharmaceutical goods are produced, have to meet demanding market requirements regarding quality assurance for manufacturing. They have to comply with large numbers of national and international standards in order to guarantee a product’s safety and quality.

We are present throughout the world with a comprehensive portfolio of innovative solutions for sensors and process monitoring systems: your ideal partner in every phase of medical device manufacturing – from the design concept, product development and qualification phases all the way through to production.

Quality assurance – producing medical devices in compliance with 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.
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Compliance with national and international standards and regulations is the essential and fundamental requirement for the manufacture of products in the medical technology sector.

Good Manufacturing Practice (GMP)

Regulatory requirements/standards:
FDA 21 CFR part 11
EU GMP Annex 11: Computerized Systems
FDA 21 CFR part 820
Medical Device Regulations (MDR)

Cavity pressure and temperature sensors, the ComoNeo 4.1 process monitoring system and new miniature sensor for hot runners.
A high precision measuring chain with dynamometer, laboratory charge amplifier and software enables objective comparison tests.
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