Our work

There are over half a million medical devices available on the UK and European markets, covering everything from in vitro diagnostic devices, surgical instruments and implants to contact lenses and wheelchairs. With recent regulatory changes – the introduction of the UKCA mark in Great Britain and the Medical Devices Regulation coming into force in Europe – companies are faced with a daunting task to ensure continuing compliance. Thanks to our extensive expertise, and close partnerships with analytical and testing laboratories and regulatory experts, we are the ideal partner for assessing the toxicological safety of your medical devices.

Biocompatibility

The basis for the biological evaluation of medical devices is the ISO 10993 family of international standards. This provides a framework for the chemical characterisation, biological testing and toxicological risk assessment (TRA) of medical devices. We are expert at conducting biocompatibility assessments, reviewing new or existing test data and conducting TRAs (in line with ISO 10993-17) based on analytical studies. Using the ISO standards and other guidance published by regulators including the US FDA and European Commission, we can provide an evaluation of the full range of endpoints required.

Extractables and Leachables

The health risk assessment of extractable or leachable chemicals that can migrate from medical devices (and subsequently reach the patient) is critical part of establishing biological safety. Within the ISO 10993 framework, extractables and leachables (chemical characterisation) studies play a critical role in understanding the composition of a device.

Change Control

When a single component of a medical device undergoes a change – for example, a different source of a raw materials – it is necessary to evaluate the impact this will have on patient safety. We are very experienced in carrying out the sort of comparative assessments and concluding on their bioequivalence.

Our Expertise

Our team has been at the forefront of the medical device E&L sector for many years. Pete Watts, one of our Toxicology Directors, and Senior Toxicologist, Chris Waine, are regular presenters at E&L conferences. Chris is also an expert member of the BSI and ISO committees developing the 10993 series of standards for the biological evaluation of medical devices, including E&Ls testing and toxicological risk assessment - read more about the newly released International Standard ISO 10993-17 in our blog post.

Our expertise in this area

Hazard Characterisation

Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities.

Risk Assessment

Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.

Testing Strategies

We can offer advice on the practicalities of designing a testing programme and will support you from approving the protocols to reviewing the final reports.

Some of our case studies in this area

Knowledge is key. Part 2: The bibra TRACE database (and supporting databank)

Blog articles

In Part 1, Peter Watts gave a potted history of his personal early experience in literature searching and toxicity data identification. Along with our colleagues of the same 'fine vintage', he weathered the storms of change, progressing from a time of back-strain (from carrying huge texts around) and index finger wear (turning pages) to dial-up and then to web-based searching. With your indulgence, Pete would now like to expand a little regarding TRACE and its value to clients and the bibra toxicologists.

Knowledge is key. Part 1: Toxicity literature searching, a personal history

Blog articles

Our Toxicology Director, Peter Watts, has written a very interesting article focussing on toxicity literature searching, from his own perspective (having been at bibra for 40+ years)

An overlooked aspect of organophosphorus compound neurotoxicity

Blog articles

Organophosphorus compounds (OPs) are widespread in both the natural and industrial worlds. Being major components of DNA and cell membranes, their diverse chemical properties are fundamental for the biology of life. But they also find uses in a range of anthropogenic applications, for example, as flame retardants, plasticisers, antioxidants and, perhaps most famously, as pesticides.

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