With our team of biocompatibility specialists, you’ll get the endpoint data collection and detailed reporting you need for regulatory submission—as well as the confidence in knowing it’s done right, the first time. From raw material to device prototype or finalized device evaluations, we have tests at the speed and efficiency needed to accelerate you forward.
GIVE YOUR DEVICE A HEALTHY START
Given the importance of this stage in development, we partner with you to efficiently and effectively navigate the required biocompatibility testing you’ll need by providing customized testing programs aligned to your material or device in question.
Full range of biocompatibility studies including non-animal alternatives
Full range of 10993 studies, biological, planning and toxicological risk capabilities
125,000 square feet of state-of-the-art, ISO 17025 GLP-accredited global facilities with multidisciplinary labs, animal model facilities and clinical/bioanalytical support
What is biocompatability testing?
In preclinical medical device development, biocompatibility testing determines the safety of the materials that make up a medical device or combination product by proving they are free from potential hazards such as toxicity, allergic reactions, other adverse effects and the manufacturing processes to which they are exposed. This step is critical in making sure your device or product complies with various global regulatory guidelines and requirements. Getting quality testing and reporting is critical in preventing delays in development and avoiding unnecessary costs.
Get a full testing strategy tailored to your product’s needs
We draw on over 40 years of experience in biocompatibility testing for medical devices and raw materials to meet global regulatory standards and make sure the proper assessments for biological hazards, risk characterizations and toxicological risks are conducted. We’ll collaborate with you to identify the tests and risk assessments needed to move your product to the next stage of development. With our streamlined approach to understanding the material or device in question, you’ll benefit from high-quality scientific data, analytical support and shorter timelines that help your device advance quickly and more efficiently—reducing your overall time to market.
Our full range of biocompatibility testing services includes:
- Biological evaluation plans and risk assessments (ISO 10993-1)
- Genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3 and 33)
- Hemocompatibility (ISO 10993-4 and ASTM)
- Cytotoxicity (ISO 10993-5)
- Implantation (ISO 10993-6)
- Sensitization (ISO 10993-10)
- Systemic toxicity (ISO 10993-11)
- Material-mediated Pyrogenicity test (ISO 10993-11/rabbit pyrogen) (USP <151>)
- Chemical characterization and allowable limits (ISO 10993-17 + 18)
- Irritation (ISO 10993-23)
- Bacterial endotoxins LAL (USP <85> and ANSI AAMI ST72)
- Biological reactivity tests, in vitro (Cytotoxicity) (USP <87>)
- Biological reactivity tests, in vivo (Class Test) (USP <88>)
- Plastic packaging systems and materials of construction (USP <661>)
- Japanese MHLW and international pharmacopoeias
Count on our extensive experience to keep your device moving forward.
Reasons to need biocompatibility testing
Beyond assessing the potential risk of your new device or combination product, biocompatibility testing offers the following benefits:
- Assesses the impact of a design change or new manufacturing process on your device’s safety
- Evaluates new raw material suppliers
- Considers effects of sterilization techniques or long-term material stability
- Generates toxicology reports
- Establishes biological evaluation plans
- Conducts gap analyses of existing biocompatibility dossiers
- Fulfills requests for additional information from regulatory bodies
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We know that your medical device or combination product has the potential to bring greater outcomes to patients in need. That’s why we share your mission to advance your medical devices and combination products with a sense of urgency. We work with your goals and milestones in mind and will partner with you to reach them on time. From developing clear road maps to communicating proactively, we work with speed and efficiency at every turn to keep pace with your important milestones.
* 5 year data from 2017– 2021