Neutral testing and proof for medical devices.
From patient safety to product development to complaint prevention and marketing, lives depend on it.
Hohenstein is an accredited testing laboratory for medical products. We provide neutral proof of efficacy and safety or customized testing for development and comparison.
- Biological, microbiological-hygienic and physical laboratory tests
- Technical documentation
- Testing to standards or manufacturer specifications
- Performance assessment and development
- Perspiration, urine and wound odor
- Comfort (skin and microclimate, breathability, thermal insulation)
- Fit and Pattern (pattern development, fit testing, body measurement data, 3D/4D scanning)
Regulatory Affairs Blog
Articles by Hohenstein and our partner, seleon, on medical device approval.
- ISO 18562 standard series – Biocompatibility evaluation of breathing gas pathways in healthcare applications
- Testing for cytotoxicity: The “well-established” EN ISO 10993-5
- Tests for irritation: The EN ISO 10993-23 extends the series of standards
- MDR requirements for medical devices also apply to compression stockings
- Blurb! What is that?
- Post-pandemic masks