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Biological Evaluation and Biocompatibility Course & Certification
Intermediate
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4.4
★★★★★
97% Recommended
Updated 2026
3 hours
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CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
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Affordable
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Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with ISO 10993-1:2025 (Edition 6, published 18 November 2025) — the current edition, which replaces ISO 10993-1:2018, removes the prescriptive Table A.1 and places biological evaluation within a risk-management process — together with the FDA's partial recognition of ISO 10993-1:2025 (updated 25 May 2026), which does NOT recognise Clause 6.9 because it conflicts with ISO 14971:2019, and the FDA guidance 'Use of International Standard ISO 10993-1' (2023), which remains operative; ISO 14971:2019 and ISO/TR 24971:2020 (a technical report, i.e. guidance); ISO 10993-18:2020 with Amendment 1:2022 (chemical characterisation, home of the AET); ISO 10993-17:2023 with Amendment 1:2025 (toxicological risk assessment, introducing the TSL); ISO 10993-12:2021 (sample preparation); ISO 21726 (the TTC); the individual ISO 10993 test parts; and Regulation (EU) 2017/745 (MDR), as our training courses are constantly monitored, reviewed and updated. Standards positions were verified in July 2026 and must be re-verified against the sources themselves before use.
Learn from Industry Experts
The course content is Whitehall Training editorial material, developed to reflect established practice in the biological evaluation of medical devices — the way an evaluation is actually run under ISO 10993-1:2025 inside an ISO 14971 risk-management process, and the failure modes that turn up when it is not. It is built around a single fictional case study, VascuPort Flex, with a canonical set of materials, constituents and changes, so that every characterisation, chemistry, toxicology and endpoint decision in the course is one the learner can reason through for themselves. Standards, technical reports, regulations and guidance are paraphrased and clause-referenced; they are never reproduced, and no product- or substance-specific toxicological conclusion is offered.
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About
Biological Evaluation and Biocompatibility training provides professionals with the knowledge required to assess the biological safety of medical devices throughout their lifecycle. The course explains the principles of biological risk assessment, material characterization, and the application of the ISO 10993 series to ensure devices are safe for their intended clinical use while meeting global regulatory expectations.
This Biological Evaluation and Biocompatibility Training Course & Certification covers ISO 10993 requirements, biological evaluation planning (BEP), biological evaluation reports (BER), material selection, toxicological risk assessment, cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation studies, chemical characterization, risk management integration, and regulatory documentation. Upon successful completion, learners receive a certification demonstrating their understanding of biological evaluation processes and biocompatibility requirements for medical devices.
Who Should Enrol?
- Medical Device Design and Development Engineers
- Quality Assurance and Quality Control Professionals
- Regulatory Affairs Specialists
- Risk Management and Product Safety Professionals
- Clinical Affairs and Research Personnel
- Testing Laboratory and Validation Professionals
- Manufacturing and Process Engineers
- Anyone involved in medical device development, testing, regulatory compliance, or biological safety evaluation
What you will learn
Understand the principles of biological evaluation, biocompatibility, and their importance in ensuring the safety and performance of medical devices.
Learn the requirements of ISO 10993, biological risk assessment, material characterization, and the selection of appropriate biocompatibility tests.
Develop knowledge of cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation studies, and other biological evaluation endpoints.
Gain understanding of biological evaluation planning, risk management integration, test report interpretation, regulatory expectations, and documentation required for medical device compliance.
Course Syllabus
- Biological safety, biocompatibility, biological risk — defined and distinguished
- Biological evaluation, biocompatibility testing and toxicological risk assessment told apart
- ISO 10993-1:2025 (Edition 6, 18 November 2025): risk-based, and Table A.1 removed
- Biological evaluation inside the ISO 14971 risk-management process
- FDA partial recognition of ISO 10993-1:2025 (excludes Clause 6.9) and the 2023 FDA guidance
- The structure and role of the ISO 10993 series
- The EU MDR frame and where biological evidence sits in technical documentation
- Defining the device, its intended use and the nature and duration of body contact
- Contact categories and contact duration (transient / short-term / long-term)
- Identifying materials, additives, processing aids, residues and degradation products
- Manufacturing and sterilisation as sources of constituents
- VascuPort Flex: components, materials and EO residuals (EO, ECH, EG)
- Supplier data as an input to appraise, not automatic proof
- Common failures: the constituent nobody characterised
- Module 2 recap and knowledge checks
- Developing a Biological Evaluation Plan
- Evaluating existing biological, chemical, clinical and post-market evidence
- Appraising evidence for relevance, quality, comparability and completeness
- Identifying data gaps and uncertainties honestly
- Equivalence and its limits for materials and processes
- VascuPort Flex: building the plan and appraising the evidence base
- Common failures: the gap that was assumed away
- Module 3 recap and knowledge checks
- What chemical characterisation is — and is not
- Extraction strategy: solvents, time, temperature, surface-area-to-volume ratio
- Exaggerated, simulated and exhaustive extraction
- Analytical methods, identification and quantification of constituents
- The Analytical Evaluation Threshold (AET) and its uncertainty
- Extractables, leachables and manufacturing and sterilisation residuals
- VascuPort Flex: change CH-05 and an unknown above the AET
- Module 4 recap and knowledge checks
- Toxicological hazard identification and exposure estimation
- Point of departure, uncertainty factors, tolerable intake and margin of safety
- The Toxicological Screening Limit (TSL) and the threshold of toxicological concern (TTC)
- Chemistry informs toxicology — it does not replace it
- Working a margin-of-safety conclusion, with every assumption stated and labelled fictional
- VascuPort Flex: assessing the unknown extractable from CH-05
- Common failures: hazard mistaken for risk; a conclusion without exposure
- Module 5 recap and knowledge checks
- Selecting biological endpoints using a risk-based rationale, not Table A.1
- When in vitro, in vivo or alternative methods may be appropriate, and the 3Rs
- Cytotoxicity, sensitisation, irritation and systemic toxicity endpoints
- Genotoxicity, implantation, haemocompatibility and degradation considerations
- Material-mediated pyrogenicity versus bacterial endotoxin, kept distinct
- VascuPort Flex: an endpoint matrix for a long-term blood-and-tissue-contacting implant
- Common failures: a test battery chosen by category alone
- Module 6 recap and knowledge checks
- Integrating biological risk controls into design and manufacturing controls
- Writing a defensible Biological Evaluation Report — not a laboratory report
- Weight of evidence, residual risk, benefit-risk and traceability to the risk file
- Preparing biological-evaluation evidence for EU and US submissions
- How the BER and its inputs map into technical documentation
- VascuPort Flex: assembling the report and the submission evidence
- Common failures: the report that only stapled lab results together
- Module 7 recap and knowledge checks
- Assessing biological-safety impact when materials, suppliers or processes change
- Sterilisation and packaging changes and their biological consequences
- The change-impact assessment: what is affected, what remains valid, what to re-evaluate
- Legacy devices and gap assessment against ISO 10993-1:2025
- VascuPort Flex: working changes CH-01 to CH-04
- Post-market information feeding back into the evaluation
- Common failures: the 'same grade' change that was never re-assessed
- Module 8 recap and knowledge checks
- Describe the biological evaluation process from end to end
- Explain how the evidence chain reaches a defensible conclusion
- Recognise and avoid the common failures
- Prepare confidently for the final assessment
- 📘 Bonus: Biological Evaluation and Biocompatibility eBook (Free with purchase)
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