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
Value delivered to our clients
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.