Medical Devices

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

For more than 20 years Nelson Labs Europe has been a well-known partner throughout the medical device industry in Europe. Nelson Labs Europe has become a solid partner who can guide you through the preclinical regulatory landscape in order to facilitate your product's 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, sterilization support, genetic and molecular toxicology, reusable device and combination product evaluations, and more.

 

Nelson Labs Europe offers medical device testing services consisting of:

 

Material Characterization and Biocompatibility (ISO 10993)

  • Chemical characterization, identification and quantification of leachables
  • Determining 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, ...

 

Toxicology & Biocompatibility (In Vivo) – ISO 10993

  • Nelson Labs Europe offers a full range of in vivo test services on a subcontract basis through qualified partner labs.
  • We can assist you with in vivo studies for Sensitization, Irritation, Systemic Toxicity, Sub-chronic Toxicity, Implantation Studies, Genotoxicity, Thrombogenicity, and other required tests per ISO 10993 for US FDA submissions.
  • Consult required for testing intended for submission to European Union (EU), Japanese (MHLW) and other notified bodies. Contact the Sales Department at InfoEurope@nelsonlabs.com for more information or for consultation on in vivo test services.

 

**Custom biocompatibility in vitro and in vivo studies and consultations are available. ISO 10993 biocompatibility summary report, highlighting biocompatibility testing results and conclusions, is also available upon request. For more information contact Sales at InfoEurope@nelsonlabs.com.

 

Contact:

 

Nelson Labs Europe
Romeinsestraat 12
B - 3001 Leuven
+ 32 16 40 04 84

InfoEurope@nelsonlabs.com

 

Mrs. Cindy Claes
Customer Service Medical Device
ciclaes@nelsonlabs.com

 

 

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Nelson Labs Europe | Medical Devices
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