BEP / BERBEP vs BER: the Biological Evaluation Plan and Report explained
What goes into a Biological Evaluation Plan and a Biological Evaluation Report, how they differ, and why regulators expect both.
Read the guideInsights
Guides from our toxicologists
Clear, practical explanations of biocompatibility, ISO 10993 and the biological evaluation process for medical device teams.
BEP / BER
Toxicological Risk AssessmentCan you reduce biocompatibility testing? The role of chemical characterisation and risk assessment
How chemical characterisation (ISO 10993-18) and toxicological risk assessment (ISO 10993-17) can justify fewer animal tests.
Read the guide
ISO 10993-1How medical devices are categorised for biological evaluation under ISO 10993-1
Nature of body contact and duration of exposure decide which biological endpoints apply to your device. Here is how categorisation works.
Read the guide
Ready to make your device submission-ready?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.