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Medical Device Testing

Biocompatibility Testing

Biocompatibility testing or ‘Biological Evaluation of Medical Devices’ (as set out in ISO standard series 10993) is a set of guidelines and testing parameters for assessment of medical device safety before any medical device comes to market. The standard uses a risk management approach for each device, reviewing existing data on materials and conducting supplementary tests where appropriate. It is necessary to look at how the medical device will be used; specifically, what the nature of the body contact will be, and the contact duration.

The ISO 10993 implications must be considered from the outset of medical device design, and the balance struck between device functionality and toxicity to the body. Assessment of other influencing factors such as leachables, residues and contaminants should also be considered at this stage.

Our Biocompatibility Testing:

We offer a full suite of medical device testing under ISO 10993 (including genotoxicity, haemocompatibility, and pyrogenicity), however, we most frequently perform 10993-5; in vitro Cytotoxicity Test. This test was introduced as part of our commitment to the use of alternative methods wherever possible and allows us to use a non-animal model to assess any potential detrimental effects of medical devices or their components, in a highly controlled manner.

We are proud of our extensive knowledge and experience in this field; as such, we can advise on the most appropriate methods for the testing of your medical device. If your biocompatibility testing requirements cannot be fully conducted in-house, we also work with several approved partners to provide a full range of testing methods, for the ISO 10993 series.

GLP Offerings:

For Medical devices being submitted for regulatory approval you may require GLP compliance from your biocompatibility testing. As such, we are equipped with MHRA GLP certification and maintain an up to date understanding of GLP regulations as they progress and change.

When GLP compliance is required and some of your testing cannot all be conducted in-house; our approved partners are also GLP compliant and have been audited by our quality assurance team. Studies with our approved partners are conducted as Multi-site studies to keep work compliant while not imposing extra complexity on you.

Biocompatibility Testing FAQ

Which tests will my product need?

Testing requirements vary based on the usage of your medical device. This is based on:

Contact type such as implantation versus surface devices
Specific contact point such as intact skin versus breached skin
Contact duration

Our team will be able to work with you to determine what you will require.

Why use GLP?

GLP standards are a requirement by some regulatory bodies, such as the FDA, for the non-clinical phase of approval for medical devices. Therefore, any device looking for approval in these markets will need to go through this GLP stage.

Do I need GLP for preliminary biocompatibility studies?

GLP compliance can only be claimed on studies to be submitted for approval with a regulatory body. However, the principles and regulations that give GLP studies their reliability and integrity are still applied in our non-GLP studies.

What are the extra requirements of a multi-site GLP study?

When initiating a multi-site GLP study the client is designated as the study Sponsor. In that position, there is minimal difference between multi-site and single-site studies. We handle the arrangements with our approved partners, the distribution of samples, the collating of data, etc.

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