Medical devices require proof of efficacy.

From consumer safety to product development to complaint prevention and marketing, the evaluation and documentation is extensive.

Neutral testing and proof.

Hohenstein is an accredited testing laboratory for medical products that provides the neutral proof of the efficacy and safety that is a prerequisite for being approved or recognized as a medical poduct, such as for medical and surgical devices, disinfectants and compression textiles.

  • Preparation of technical documentation
  • Advice on clinical evaluation plans
  • Biological, microbiological-hygienic and physical laboratory tests
  • Product checks for cytotoxicity, skin irritation, sensitization etc. 
  • Research on the barrier effect of surgical textiles or on the determination of the biocidal effect in instrument disinfection, surface disinfection and disinfecting washing procedures
  • Valuable preclinical data on biocompatible and hemocompatible coatings for medical products collected from innovative test protocols

Start with product development.

Contact
Ben Mead
Managing Director
Hohenstein Institute America