Precision Medtech Services

From idea to production.
From evidence to market.

Since 1983, Denti System has been developing and manufacturing medical devices. We still have our own CE-marked products on the European market today, giving us first-hand experience across the complete medical device lifecycle. We are not only a manufacturer and not only a regulatory consultant. We understand the medical device behind the drawing.

PROTOTYPING & SMALL-BATCH PRODUCTION

For technically demanding projects where flexibility matters more than
mass-production volume.

  • Prototypes and pilot batches
  • Custom abutments and precision components
  • Small-series CNC production
  • Prototype – validated production
  • Qualified second-source manufacturing

 

Already have a supplier? Keep them.
We can become your European second source.

ISO 5 CLEANROOM SERVICES + human resource

High-quality cleanroom work for small and specialised batches. Our ISO 5 cleanroom combines a high-level controlled environment with flexible skilled manual labour – ideal where dedicated automation is unnecessary or uneconomical.

  • Manual packaging and assembly
  • Inspection, sorting and labelling
  • Pilot and validation batches
  • Special projects and rework

MDR, TESTING & CLINICAL SUPPORT

Not only documentation. We help generate the evidence behind it.

  • MDR technical documentation
  • Gap analysis, risk management, GSPR
  • Clinical evaluation, PMS / PMCF
  • Notified Body support
  • Clinical investigation management
  • Biological, oral-biological and mechanical testing coordination through
    accredited and university-backed laboratories

EXPERIENCE THAT MATTERS

Dental implants since 1983 • Own CE-marked products •
GoldLily & GoldBell IUD experience • Medical device cleanroom packaging • Implant and surgical instrument prototypes