--- title: "Biocompatibility & Biological Evaluation Solutions | QbD Group" description: "QbD Group supports medical device manufacturers with end-to-end biocompatibility and biological evaluation under ISO 10993, from feasibility to submission-ready BER." url: https://qbdgroup.com/en/services/toxicology/biocompatibility-biological-evaluation type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Biocompatibility & Biological Evaluation Solutions | QbD Group\", https://qbdgroup.com/en/services/toxicology/biocompatibility-biological-evaluation" --- # Biocompatibility & Biological Evaluation Solutions Biological safety is not just a box to check, it is a regulatory critical step towards approval Biocompatibility is the ability of a medical device to perform its intended function without causing an unacceptable adverse biological response in the human body. As medical device regulations become increasingly risk-based and scientifically demanding, biological evaluation is a strategic component of regulatory success for a smooth conformity assessment. With ISO 10993-1:2025 introducing a significantly revised, risk-management-oriented framework, manufacturers need more than a testing laboratory, they need the right scientific and regulatory strategy from the outset. ## The role of biological evaluation in medical device approval Biological evaluation answers a fundamental question: **is this device safe for the body, considering how, where, and for how long it is used?** Biocompatibility is not a single test. It is a **structured, risk-based evaluation process governed by the ISO 10993 series**. A biological evaluation is required whenever a device is newly developed and submitted for the first time, when materials or suppliers affecting patient-contacting components change, when manufacturing, sterilisation, or surface treatment changes, when the intended use or patient population is extended, or when post-market surveillance raises a new safety signal. ## ISO 10993-1:2025, what's changed ISO 10993-1:2025 (6th edition) supersedes the 2018 standard. These five changes shape how biological evaluations must be structured going forward. ### Closer alignment with ISO 14971 ISO 14971 risk language is used throughout, biological equivalence is formally defined, and biological risk estimation and control are now explicit evaluation steps. ### Reorganisation of biological effects The single Annex A matrix is replaced by contact-type specific tables, "endpoints" are renamed "effects," and material characterisation moves into biological risk analysis. ### Exposure duration made more precise The "contact day" concept is introduced so any contact counts as a full day, intermittent-use rules are clarified, and many devices face re-categorisation as a result. ### Lifecycle and animal welfare emphasis Full lifecycle evaluation is specified in more detail, with the 3R principle further substantiated and in vivo testing reserved for cases with strictly no alternative. ### Reasonably foreseeable misuse now in scope Not just intended use, predictable misuse such as longer exposure, a different site, or a different population must be evaluated with the same rigour. ### Not sure which changes apply to your device? Our toxicologists can help you assess the impact and define the right next steps. ## How QbD Group supports your biocompatibility strategy Integrated services delivering complete biological evaluation under ISO 10993. Reports are signed and verified by EUROTOX-registered toxicologists (ERT), the European standard for professional toxicology practice. ### Feasibility / gap analysis Early-stage biological evaluation feasibility assessment to define the initial roadmap, or gap analysis of existing documentation against the latest ISO 10993-1 requirements. ### Biological Evaluation Plan and Report (BEP/BER) authorship ISO 10993-1 compliant BEP defining scope, endpoints, and testing strategy, followed by a full BER that integrates all data into a submission-ready biological safety package. ### Toxicological risk assessment ISO 10993-17 compliant exposure estimation, TDI/TTC derivation, margin of safety calculation, and QSAR/SAR-supported justification by ERT-certified toxicologists. ### Chemical characterisation and E&L ISO 10993-18 gap analysis, AET/LOD/LOQ assessment, extractables and leachables evaluation, and identification and hazard characterisation of device constituents. ### ISO 10993 testing coordination Selection and management of ISO 17025 accredited labs, protocol review, raw data oversight, and technical adequacy assessment across all required endpoints. ## Our process A stepwise, risk-based approach that takes a device from initial feasibility to a submission-ready biological evaluation. ### Feasibility / gap analysis Define the biological evaluation roadmap for early-stage development, or assess an existing device against the latest ISO 10993-1 requirements. ### BEP definition Author a complete Biological Evaluation Plan aligned with ISO 10993-1, defining endpoints, testing strategy, and rationale. ### Data generation Coordinate ISO 10993 testing with accredited labs and run chemical characterisation and E&L evaluation in parallel. ### Toxicological risk assessment Derive exposure estimates, TDI/TTC, and margin of safety, and integrate the findings with the BEP strategy. ### BER authoring Deliver a full, submission-ready Biological Evaluation Report integrating all data, testing results, and expert conclusions. ## From biological evaluation plan to submission-ready report The Biological Evaluation Plan (BEP) is the foundation of every biological evaluation. It is a structured document within a risk management process that assesses the biological risks posed to patients, defining biological endpoints based on device classification and patient contact, and setting out a clear, **risk-based rationale** for the testing and literature strategy. The Biological Evaluation Report (BER) is the culmination of that process. It **interprets the BEP and the findings of the biological evaluation into one report**, integrating testing results, literature, chemical characterisation, and toxicological assessment into comprehensive, expert conclusions on safety. Where a device changes, whether in design, materials, manufacturing, or sterilisation, a **Change Control Assessment (CCA)** determines whether the change introduces new biological risks, updated testing needs, or a revised BER, keeping the biological evaluation current across the device lifecycle. ## Value delivered to our clients From initial assessment to final justification, our Biocompatibility Report provides a complete, decision-ready package. #### Stronger regulatory defensibility Clear justification for endpoints, waivers, assessment factors, and use of predicate or historical data, aligned to ISO 10993 expectations. #### Fewer unnecessary in vivo studies Risk-based use of literature and SAR/QSAR supports scientifically justified testing reduction, saving cost and time while maintaining compliance. #### Audit-ready documentation Structured, traceable reports with transparent calculations and referencing that support EU MDR and FDA review. #### Submission readiness by design Peer-reviewed deliverables with expert sign-off, organised for immediate inclusion in regulatory filings and lifecycle updates. Why QbD Group ## Your trusted partner For more than a decade, we have provided reliable, science-driven biological evaluations that help medical device manufacturers meet ISO 10993 and evolving global regulations. 10+ years of biosafety expertise deep specialisation in ISO 10993-1 and medical device testing, recognised by competent authorities, supporting clients from idea to patient as a full-service partner. EUROTOX-certified toxicologists (ERT) all biological evaluation reports are authored and reviewed by EUROTOX-registered toxicologists, the recognised European standard, with 10,000+ reports delivered to date. EU MDR & FDA alignment our reports have been reviewed and accepted by EMA, FDA, and local authorities, supporting 200+ biological evaluations across implantables, combination products, and skin-contact devices. Lab-independent, risk-based approach we coordinate with ISO 17025-accredited laboratories across Europe, reviewing raw data and study protocols on the client's behalf, independent of any lab's commercial interests, having supported 1200+ start-ups, scale-ups, and industry leaders in Life Sciences. ## Let's talk Biocompatibility From feasibility assessment to submission-ready BER, our biocompatibility experts are ready to support your medical device program. Contact us --- Source: https://qbdgroup.com/en/services/toxicology/biocompatibility-biological-evaluation — © QbD Group. Quote freely with attribution and a link back.