Biocompatibility: A Critical Step in Medical Device Safety & Market Access

Biocompatibility testing is a cornerstone of medical device development. Even the most well‑designed products can pose unintended patient risks if materials trigger adverse biological reactions due to contamination, degradation, or the leaching of toxic compounds. 

With 40+ years of expertise, our ISO 17025‑accredited laboratories support medical device manufacturers of all sizes in preparing products for global market access through three independent but integrated services: consulting, testing, and sterile packaging. 

Ready to de‑risk your device and accelerate regulatory approval? 

Schedule a call with Bruna Coelho dos Santos Manoel, M.D., MBA Head of Medical Device Testing, Nordics Book here
Eurofins BioPharma Product Testing Denmark A/S 

Our multidisciplinary teams of veterinarians, chemists, and toxicologists provide end‑to‑end biocompatibility support, including: 

• Chemical characterization of degradation products
• Extractables & leachables testing
• Toxicological risk assessments
• Biological evaluations aligned with international regulations 
  
  

Want deeper insights? 

Watch the webinar recording: 
“Biocompatibility Testing: In vitro versus in vivo – Recent developments and regulatory acceptance” 
Request the recording here

Or request our latest white paper: 
“In vitro versus in vivo biocompatibility studies – European vs US FDA requirements (2025 update)” 
Request the whitepaper here

At Eurofins Medical Device Testing, we support companies across the entire device lifecycle, from development to post‑market, through our global network of regulatory experts, 20+ laboratories, and 2 sterile packaging sites across Europe, North America, and Asia‑Pacific.