The simple, easy to edit Biological Evaluation Plan template as per ISO 10993 is officially available! Buy it now!



Biological Evaluation Plan – template

The Biological Evaluation Plan template is an essential document in every manufacturer’s Technical File. It helps break down the raw materials used in the make-up of your device as well as includes as easy to populate table showing which tests were selected for your device as per ISO 10993. After purchasing, you will receive a word document that is ready to edit. You will receive a copy of the Biological Evaluation Plan template within 24 hours of payment.


This plan is written for new manufacturers with low-risk devices that are looking for a simple-to-populate template.

The plan includes:

  • Purpose and Objectives
  • Applicable standards
  • Scope and Description
  • A simplified categorization of the device – this section includes a prompt to consider a summary of your device components and details
  • Overview of biological effects considered
  • Justification for those effects not considered

For higher risk devices, we suggest purchasing our more detailed Biological Evaluation Plan for high-risk devices.