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JL Tox Consulting is a reliable and experienced partner for companies in the medical device industry. Our services cover all stages of medical device biocompatibility, from the initial product design to its lifecycle management. Our expertise includes in vitro and in vivo biological testing, chemical characterization, and toxicological risk assessment, aligning with regulatory agencies' expectations worldwide.

We understand the importance of meeting regulatory requirements for medical devices. We can guide you through the process, ensuring that your product meets all the necessary standards to gain approval. Our team has over a decade of experience in medical device toxicology and biocompatibility, giving us the knowledge and skills to assist you in achieving your project's successful completion.

We pride ourselves on providing personalized services tailored to meet your needs. Our team works closely with you to understand your goals, timeline, and budget and develop a customized strategy to drive your project forward. We aim to help you achieve your objectives while adhering to regulatory requirements and ensuring patient safety.

If you need a trusted partner for your medical device project, JL Tox Consulting is here to help. Our services and expertise span the entire biocompatibility spectrum, and we are committed to delivering successful outcomes for our clients. Whether you need help with testing, risk assessments, or anything in between, our qualified team is dedicated to providing exceptional consulting services to get your medical device approved and on the market as quickly as possible.

Contact us to schedule a consultation with our experts today!

Our Services & Expertise

Biocompatibility Test Plan

  • ISO 10993-1 (2018) Biocompatibility test plan

  • Leachable and extractable design and risk assessment

  • Biocompatibility gap assessments

  • Design and manufacturing change impact assessments

  • CAPA and MDR Remediation

  • CRO and Test Lab communication and guidance

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Chemical Characterization

  • ISO 10998-18 (2020) extractable and leachable study design

  • Solvent compatibility and feasibility study design

  • Toxicological risk assessment of extractable and leachable data

  • CRO and Test Lab communication and guidance

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Toxicological Risk Assessment

  • Evaluation of chemical compounds according to ISO 10993-17 (2021 Under Development) 

  • Calculation of safe and allowable limits

  • QSAR Analysis

  • Responses to regulatory questions and concerns

  • Evaluation of restricted substances and cohort of concern compounds

  • 45+ Successful toxicological risk assessments accepted by global regulatory agencies

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Biocompatibility Safety Evaluation

  • Biocompatibility test result analysis

  • Biocompatibility risk assessment

  • Biocompatibility Safety Report preparation 

  • Biocompatibility Safety Report preparation 

  • Expert opinion and position papers

  • Expert justification and rationales

  • Regulatory submission preparation

  • Q-Sub and notified body meeting support

  • Regulatory deficiency and additional information request support

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