Biocompatibility & TRA Toolkit: ISO 10993 Biological Evaluation Templates
Biocompatibility and TRA Toolkit — biological evaluation plan, toxicological risk assessment, chemical characterization report, test selection justification, BER summary, and FDA submission checklist.
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Frequently Asked Questions
When can chemical characterization replace biocompatibility testing?
When chemical characterization demonstrates extractables below the analytical threshold or TRA confirms they are below tolerable intake. FDA 2023 guidance provides the framework for this determination.
Which ISO 10993 edition does FDA currently accept?
FDA aligns with ISO 10993-1:2018 per its 2023 guidance. Both the testing approach and chemical characterization plus TRA approach are accepted.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your company's branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, you'll receive an email with download links within 2-3 minutes. Check your spam folder if you don't see it.
Can I use these for multiple projects or clients?
Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.
Do these templates get updated when regulations change?
Yes. You'll receive free updates via email whenever we update templates for new guidance or regulatory changes.
What if I need help customizing the templates?
Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.
Is there a money-back guarantee?
Yes — the Audit-Ready Guarantee. If you're not satisfied within 7 days, email us for a full refund. No questions asked.
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Every week without proper documentation is another week of audit exposure.