Devices

A Product and Market Consultative approach in advancing devices and combination products

For more than 20 years Toxikon Europe is a well known partner throughout the medical device industry in Europe. Toxikon Europe has become a solid partner who can guide you through the preclinical regulatory landscape in order to facilitate your products market entry. Our customized effective programs assist you in fulfilling your risk management process in a global regulatory compliance context.

Our facilities include capabilities to conduct proof-of-concept (efficacy) studies, analytical, complete biocompatibility, extractables and leachables, microbiology, sterilisation support, genetic and molecular toxicology, reusable device and combination product evaluations, and more.

 

Toxikon Europe's medical device testing services consist of:


Material Characterization and Biocompatibility (ISO 10993)

  • Chemical characterization, identification and quantification of leachables
  • Determing allowable limits
  • Toxicological assessments
  • in vitro testing (cytotoxicity and gene mutation assays)
  • in vivo testing (full range)
  • Material qualification - compendial testing (EP, USP, JP,...)

 

Efficacy Testing Modes

  • in vitro and microbiology studies: cleaning and life-cycle validations, antimicrobial efficacy, microbial ingress, Time-Kill-Kinetic assays, ...
  • in vivo testing (ESRS - Efficacy and Surgical Research Services) for customized proof of concept studies, developing surgical models and approaches, ...

Lot-Release testing and introduction of Rapid Microbiology

Contact:

 

Toxikon Europe N.V.
Romeinsestraat 12
B - 3001 Leuven
+ 32 16 40 04 84

info@toxikon.be


Mrs. Cindy Claes
Customer Service Medical Device
cindy.claes@toxikon.be

 

 

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services/devices/overview
medical device, preclinical contract research, lab work, combination devices, animal models, cardiovascular, ocular, orthopedic and neurological devices, biocompatibility toxicity, sensitization, irritation, specialized imaging, measurement and monitoring equipment