In Vivo Testing Services

 

Nelson Labs Europe’s In-Vivo Biocompatibility Testing Services for Medical Devices

The goal of in vivo testing medical devices is to determine the safety or biocompatibility of the device in a biological environment. 

Biocompatibility testing requirements comes into effect if a product is scheduled for Pre-Market Approval (PMA) or 510k submissions.  Biocompatiblity testing determines the biological reaction of a body to a product/device that comes in contact with it for a defined duration.

Nelson Labs Europe has performed numerous safety studies, which has given us good experience and knowledge for many years.  All studies are performed in compliance with guidelines established by the regulatory agencies.  The protocols are designed to meet the regulatory requirements for ISO, USP, OECD and Japanese MHLW.

 

Nelson Labs Europe offers expertise in the following product compliance testing:

Testing on raw materials for medical use compliance:

  • USP Class VI (Intracutanous , systemic and short term implantation)
  • ISO 10993 testing
  • GMP Screening evaluation testing 

 

Testing on final medical devices per ISO/FDA/MHLW:

  • Sensitization
  • Irritation/Intracutaneous Reactivity Tests
  • Systemic Toxicity (Acute)
  • Toxicity Tests (Subacute to Chronic)
  • Implantation Tests
  • Carcinogenicity
  • Immunogenicity
  • Dermal
  • Ocular

 

Testing in support of Basic Research Phase (ESRS): Efficacy Surgical Research Services

  • Consulting
  • Space Rental
  • Physician Training/Bioskills lab
  • Early Discovery
  • Proof of Concept
  • Surgical Studies
  • Interventional Cardiology
  • Orthopedic Studies
  • Non-Routine Feasibility

Contact:

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

InfoEurope@nelsonlabs.com

 

Ms. Cindy Claes
Customer Service Medical Device

ciclaes@nelsonlabs.com

Nelson Labs Europe | In Vivo Testing Services
biocompatibility, molecular biology, virology, metabolism, genetic toxicology, molecular toxicology, immunotoxicology, cytotoxcity, assays, binding assays, preclinical in vitro services, in vitro studies, contract research organziation, CRO,