Safer Medical Devices – In Vitro Skin Sensitization Testing with Human Relevance and High Accuracy

Medical Device, Medical Device Safety and Regulation, Medical Device Manufacturing & Supply Chain,
  • Wednesday, October 21, 2020

Join this webinar to learn how combining genomics and machine learning provides a highly accurate in vitro method for assessment of skin sensitization hazard in medical device extracts, prepared according to ISO 10993-12.

Featured speakers will introduce how the GARD technology and the GARDskin Medical Device assay were developed, with a focus on the technological origins of the high predictive performance. We will also demonstrate how the results can be used for risk assessment and decision-making in compliance with the principles of the 3Rs.

The GARD™ Technology: Genomics and Machine Learning

Predictive toxicology is a discipline that aims to proactively identify adverse human health and environmental effects in response to chemical exposure. GARD – Genomic Allergen Rapid Detection™ – is a next-generation, animal-free testing framework for assessment and characterization of chemical sensitizers. The GARD platform integrates state-of-the-art technological components, including human immunological cells, specific genomic biomarker signatures and machine learning-assisted classification models.

As a result, the GARD platform provides an accurate, cost-effective and efficient assessment of skin sensitizing capabilities of neat chemicals, complex formulations, mixtures and materials, including finished medical devices. GARD assays are successfully applied throughout the product life cycle of chemical, life science and medical device industries.

Extraction Vehicles According to ISO 10993-12

The GARD™skin Medical Device assay is an adaptation of SenzaGen’s skin sensitization test for chemicals, GARD™skin. The medical device adaptation enables the medical device industry to perform skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12, thus mimicking the intended use of the device when in contact with skin. The GARD platform is also compatible with a broad selection of solvents, allowing for further analysis of extracts from chemical characterization studies. GARD™skin is currently being validated for regulatory acceptance (OECD, TGP 4.106).

A Highly Accurate and Ethical Alternative for Customers

GARD™skin Medical Device offers a solution for customers looking for a highly accurate and ethical alternative for skin sensitization testing of materials and medical devices. The webinar will conclude by presenting customer cases where the assay has been successfully utilized for risk assessment as part of the biological evaluation throughout the production life cycle. Both small and large companies have used the assay in product development, monitoring of manufacturing changes, and as a part of the regulatory approval process for finished medical devices.


Rose Marie Jenvert PhD, SenzaGen

Rose-Marie Jenvert PhD, Product Manager GARD Applications

As a Product Manager at SenzaGen, Dr. Rose-Marie Jenvert is responsible for managing new GARD applications, being the link between the market and the internal organization. She also acts as a medical device expert, contributing with her extensive knowledge from the medical device industry, previously working at Gambro/Baxter as study director for biocompatibility studies and currently as an expert in ISO/TC194 updating the standards for skin sensitization and skin irritation (ISO 10993-10 and -23). She also brings many years of experience working with R&D, method development and QA at AstraZeneca and Johnson & Johnson. Dr. Rose-Marie Jenvert holds a Master of Science in Molecular Biology from Lund University and a Doctor of Philosophy in Cell Biology from Stockholm University.

Message Presenter
Joshua Schmidt PhD, SenzaGen

Joshua Schmidt PhD, Business Development Director-Americas

In his role as the Business Development Director for the Americas, Joshua is responsible for most aspects of building business for SenzaGen in the USA and Canada. In this role, he leads the efforts to gain recognition and acceptance of the GARD assay.  To this position, he brings a wealth of technical knowledge and experience, having obtained his PhD in Pharmaceutical Sciences from the University of Wisconsin in Madison, and working for companies such as Medtronic and 3M’s Drug Delivery Systems Division. He also has over 10 years of experience in B2B and B2C sales of scientific instrumentation and analytical testing services in the pharma, med device, and other healthcare industries.

Message Presenter

Who Should Attend?

This webinar will benefit professionals working in the medical device industry, including:

  • Decision Makers
  • Safety Specialists
  • Biocompatibility Experts
  • Toxicologists

This will also be relevant to consultant companies and CROs specializing in biological evaluation and biocompatibility testing.  

What You Will Learn

Attendees will gain insights into:

  • How GARD™skin Medical Device works and why it is highly accurate and human-relevant
  • How to predict skin sensitizing hazard of materials by testing extractables directly using extraction solvents in accordance with ISO 10993:12
  • How customers use the study results in different stages of the product life cycle, for safer products and in line with the 3Rs

Xtalks Partner


SenzaGen is a Swedish biotech company that provides state-of-the-art animal-free tests for assessing whether a chemical causes allergies. The GARD™ test method combines genomic data from human cells with machine learning for a unique capability to identify and analyze whether a chemical causes allergic reactions on the skin or in the respiratory tract. With excellent predictivity, GARD™ meets needs in several industries and helps companies develop, produce and deliver safer, ethical and more sustainable products. GARD™ tests are performed in SenzaGen’s GLP-approved lab and by select partners in Europe and the US. SenzaGen has its headquarters in Lund, Sweden and a subsidiary in the US. For more information, please visit:

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