Toxikon
Labcorp specializes in preclinical medical device development, offering a comprehensive range of testing and consulting services to accelerate device development, ensure regulatory compliance, and bring greater outcomes to patients. With over 40 years of experience, a global presence, and a team of highly skilled specialists, Labcorp is dedicated to supporting medical device and combination product advancements through innovative testing solutions, expert guidance, and efficient project management.
Industries
Nr. of Employees
medium (51-250)
Toxikon
Bedford, Massachusetts, United States, North America
Products
Preclinical Medical Device Development
The initial stage of medical device development involving specialized tests to ensure safety and regulatory compliance.
Biocompatibility
Testing to ensure that device materials and manufacturing processes are biologically compatible and meet regulatory requirements.
Microbiology and Reusability Validation
Testing to confirm device sterility, reusability, and microbial contamination risk.
Analytical Chemistry
Evaluation of the chemical makeup of devices to ensure compliance with regulatory standards.
Efficacy and Surgical Services
Services to confirm device efficacy and provide surgical training and experimental surgery solutions.
Consulting and Risk Assessment
Guidance on regulatory submission processes and risk assessments to ensure compliance and market approval.
Preclinical Medical Device Development
The initial stage of medical device development involving specialized tests to ensure safety and regulatory compliance.
Biocompatibility
Testing to ensure that device materials and manufacturing processes are biologically compatible and meet regulatory requirements.
Microbiology and Reusability Validation
Testing to confirm device sterility, reusability, and microbial contamination risk.
Analytical Chemistry
Evaluation of the chemical makeup of devices to ensure compliance with regulatory standards.
Efficacy and Surgical Services
Services to confirm device efficacy and provide surgical training and experimental surgery solutions.
Consulting and Risk Assessment
Guidance on regulatory submission processes and risk assessments to ensure compliance and market approval.
Services
Regulatory consulting and risk assessment
Customized regulatory strategy, pre‑submission planning, risk management for material changes, gap analyses of biocompatibility dossiers and submission guidance for global regulatory bodies.
Analytical chemistry testing services
Method development and testing for extractables & leachables, residuals, compendial analyses, dose verification, stability studies and validated analytical reporting.
Biocompatibility testing and biological evaluation plans
End‑to‑end biocompatibility programs including biological evaluation plans, ISO 10993 study execution (in vitro and in vivo) and toxicological reporting.
Microbiology and reusability validation services
Reusable device validation, manufacturing support testing, in‑lot release (bioburden, sterility, endotoxin), environmental monitoring, packaging integrity and antimicrobial/preservative effectiveness testing.
Efficacy and surgical (preclinical) services
Protocol development and execution of in vivo surgical and efficacy studies using dedicated operating rooms, anesthesia and imaging support, physician training and GLP‑capable reporting.
Regulatory consulting and risk assessment
Customized regulatory strategy, pre‑submission planning, risk management for material changes, gap analyses of biocompatibility dossiers and submission guidance for global regulatory bodies.
Analytical chemistry testing services
Method development and testing for extractables & leachables, residuals, compendial analyses, dose verification, stability studies and validated analytical reporting.
Biocompatibility testing and biological evaluation plans
End‑to‑end biocompatibility programs including biological evaluation plans, ISO 10993 study execution (in vitro and in vivo) and toxicological reporting.
Microbiology and reusability validation services
Reusable device validation, manufacturing support testing, in‑lot release (bioburden, sterility, endotoxin), environmental monitoring, packaging integrity and antimicrobial/preservative effectiveness testing.
Efficacy and surgical (preclinical) services
Protocol development and execution of in vivo surgical and efficacy studies using dedicated operating rooms, anesthesia and imaging support, physician training and GLP‑capable reporting.
Expertise Areas
- Preclinical medical device development
- Biocompatibility evaluation and toxicological risk assessment
- Analytical chemistry and extractables & leachables
- Microbiology testing and reusability validation
Key Technologies
- Inductively coupled plasma mass spectrometry (ICP‑MS)
- Gas chromatography (GC) and GC‑MS
- High‑performance liquid chromatography (HPLC)
- Liquid chromatography–mass spectrometry (LC‑MS)