A biological evaluation for a medical device requires a structured, risk-based approach aligned with ISO 10993 and the FDA’s Guidance for Use of ISO 10993-1. Sobel supports manufacturers by developing Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), and strategic documentation that demonstrate biological safety in alignment with FDA expectations.
Sobel helps you transform historical data, material information, toxicological evidence, and scientific rationale into a strong Biological Evaluation of medical device.
Manufacturers must demonstrate biological safety using an ISO 10993–aligned, risk-based approach that meets FDA expectations for medical device submissions.
Legacy or partially documented devices often lack complete material, toxicological, or historical data, requiring structured evaluation and scientific justification.
A clear, defensible biological evaluation medical device package reduces FDA questions, avoids unnecessary testing, and strengthens your overall regulatory strategy.
With a clear strategy and well-supported justification, your submission becomes more predictable, efficient, and scientifically defensible.
At Sobel, you can request the combined BEP + BER package, or complementary toxicological and strategic services.
The most complete pathway, ensuring a consistent strategy and final reporting — reducing FDA questions, omissions, and review delays.
Toxicological review of relevant materials, components, substances, historical use, exposure, and biological safety data.
Technical guidance to define a biological evaluation strategy following ISO 10993-1 and FDA guidance, including expert recommendations for necessary tests.
RDC 848/2024 replaces RDC 546/2021 and introduces updated safety and performance requirements for medical devices, IVDs, and software. This training explains the regulation’s impact on manufacturers and importers, covering the fundamental requirements that must be met for market access in Brazil.
The European Medical Device Regulation (MDR 2017/745) represents one of the most comprehensive and complex frameworks worldwide. This training provides an overview of the MDR requirements, including classification, conformity assessment routes, technical documentation, and post-market surveillance obligations, helping companies prepare for EU compliance.
ISO 10993 is the international standard for biological evaluation, establishing how to assess biocompatibility and safety of medical devices. This training ensures that your team understands the latest updates to the standard, how to design biological evaluation plans, and how to avoid costly delays in regulatory submissions.
If you’re unsure which certification applies, Sobel provides initial guidance to map the right route and ensure full compliance.
Sobel strengthens your entire biological evaluation medical device process with complementary services that support FDA submissions:
Expert-led training programs that strengthen risk management and compliance.
Support for CEP and CER development, including strategic planning, literature reviews (LSP, LSW and LSR) and more.
Strengthen your supply chain with supplier audit and qualification services.
Let Sobel guide you through a structured, compliant, and efficient biological evaluation process for your medical device. We translate all data into a coherent, risk-based narrative that supports your FDA submission and meets global expectations.
1. What is a Biological Evaluation Plan (BEP)?
A BEP outlines the strategy, rationale, and steps your company will follow to demonstrate biological safety under ISO 10993 and FDA guidance.
2. When should I prepare a BEP for my device?
A BEP should be developed before conducting biocompatibility testing or updating historical data. It ensures that testing, justification, and data collection are aligned with the FDA’s expectations for your specific device category, materials, and patient-contact profile.
3. What is a Biological Evaluation Report (BER)?
A BER consolidates all biocompatibility data, toxicological evaluations, test results, historical information, and scientific justification into a final risk-based conclusion regarding biological safety for FDA submission.
4. When is a BER required?
A BER is required once testing and data collection have been completed, and you must present a complete biological safety assessment for 510(k), PMA, or De Novo submissions.
5. Does the FDA accept BEPs and BERs developed under ISO 10993-1?
Yes. The FDA aligns with ISO 10993-1 but applies additional expectations outlined in the FDA Guidance for Use of ISO 10993-1. A submission must satisfy both the international standard and U.S.-specific interpretations.
6. Can I use historical data instead of performing new testing?
Yes — if justified. The FDA allows the use of existing biocompatibility data, including previous testing, material information, or toxicological literature. However, justification must be scientifically sound, clearly documented in the BEP, and fully interpreted in the BER.
7. What if my device is a legacy product with outdated or incomplete biocompatibility data?
This is very common. A BEP can define a modern strategy for updating or supplementing legacy documentation. The BER will consolidate new and historical evidence, providing a risk-based conclusion aligned with current FDA expectations.
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