The detailed Biological Evaluation Plan template as per ISO 10993 is officially available! Buy it now!
This template is recommended for class II devices and higher
Detailed Biological Evaluation Plan – template
The Detailed Biological Evaluation Plan template is essential for higher risk devices and should be part of every manufacturer’s Technical File. This plan addresses: categorization of the medical device, direct and indirect contact with tissues, manufacturing process, additional contaminants and residuals that should be identified and existing biological safety data on the device. 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 manufacturers with high-risk devices that require more detail in their Biological Evaluation Plans.
The plan includes:
- Responsibilities and Authorities (details of the monitoring scientists and testing facilities)
- Biological Evaluation Plan Schedule
- Statement of Quality Assurance, GLP and Regulatory Compliance
- Purpose and Objectives on the plan
- Applicable standards
- Categorization of the device (this includes a simplified table addressing device components, suppliers and various biological safety risks)
- Direct and indirect tissue contacting materials
- Manufacturing Process
- Overview of biological effects considered
- Justification for those effects not considered
- Existing biological Safety Data available
- Packaging material risks
- and so much more!