Biological Evaluation Report

Are you looking for a streamlined and professional way to document the biocompatibility of your medical device? Our Biological Evaluation Report (BER) Template, designed in accordance with ISO 10993-1, is a comprehensive and easy-to-use tool for medical device manufacturers and regulatory teams.

Key Features:

• ISO 10993-1 Compliant: The template follows the internationally recognized ISO 10993-1 guidelines for the biological evaluation of medical devices, ensuring it meets the requirements of global regulatory bodies.
• Comprehensive Structure: Includes all essential sections needed to complete a biological evaluation report, such as device description, evaluation strategy, biological endpoints review, risk assessment, and conclusions.
• Customizable: Adaptable to your specific medical device, whether it is surface-contacting, externally communicating, or implantable. Suitable for a variety of materials and intended uses.
• User-Friendly Format: Clear instructions and section headings make it easy to fill out, ensuring accurate and organized documentation for your product’s safety profile.
• Supports Multiple Endpoints: Covers a broad range of biological endpoints including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and more, providing flexibility for different types of medical devices.
• Test Result Documentation: Space to document test methodologies, lab results, and risk assessments, ensuring a thorough analysis for regulatory submissions.
• Professional Layout: A polished and professional report template ready for submission to regulatory authorities or internal evaluations.

Why Choose This Template?

• Clarified requirements with example of how to complete the template: inside the template, you can see the requirements, how to fill out the template and an example.
• Saves Time: Avoid the hassle of building your own report from scratch. This template is designed to fast-track your documentation process, saving you valuable time.
• Regulatory Confidence: Ensure your medical device is evaluated following the gold standard in biocompatibility testing, increasing your chances of regulatory approval.
• Adaptable for All Devices: Whether you’re working on a Class IIa, IIb, or III medical device, Active or Non-active, Invasive or Non-invasive, this template is suitable for a wide range of products and materials.

What’s Included?

• Fully editable report template in Word format
• Detailed instructions for filling out each section
• Examples and placeholders for essential data
• A comprehensive checklist of ISO 10993-1 biological endpoints