The Biological Evaluation Plan (BEP) establishes a prospective, documented strategy for assessing the biological safety of a medical device, defining what needs to be evaluated, how, and on what basis, before any testing or data assessment begins.
This template provides manufacturers with the framework to build a complete evaluation strategy around the identified tests. Aligned with Regulation (EU) 2017/745 Annex I and ISO 10993-1, the BEP defines the scope, objectives, and methodology for biocompatibility assessment, evaluates existing data including material characterisation, literature, and previous studies, and considers factors such as the nature and duration of body contact, material composition, and intended clinical use throughout. A gap analysis is incorporated to identify missing information and determine what additional testing or assessments are required.
Integrated with ISO 14971 risk management requirements, the BEP ensures biological evaluation is approached systematically, with clear traceability between identified risks, evaluation methods, and supporting evidence.
This template is built by experienced regulatory professionals, giving manufacturers a structured foundation so biological evaluation is planned correctly from the outset.
Price: $600
