Biological Evaluation Plan
Loading markdown content...
Ready to generate your document?
Talk to usNo commitments required
Use this Biological Evaluation Plan template to systematically identify and document the necessary biocompatibility and biological safety tests for your medical device in accordance with ISO 10993-1. Complete this plan early in the product development process—especially for devices with patient or user contact—to ensure that all relevant biological risks are assessed and that appropriate testing strategies are established for regulatory compliance. This template is essential for guiding biological risk assessment and supporting your technical documentation for CE marking or FDA submissions.