BIOCOMPATIBILITY
At Hands on Research, we support medical device manufacturers with clear, evidence-based biological evaluation documentation aligned with regulatory expectations. Our team brings together expertise across regulatory affairs, clinical evaluation, biocompatibility testing and post-market activities, helping you assess biological safety as part of a robust and proportionate technical documentation strategy.
We can help you navigate the requirements for biological evaluation, from reviewing device materials and patient contact characteristics to identifying relevant evidence, gaps, and testing needs. Our approach is practical, scientifically justified, and cost-effective, helping you make best use of existing data and avoid unnecessary testing while maintaining a strong focus on patient safety and regulatory compliance.
Where testing is required, we support strategies that are appropriate, ethical, and aligned with current standards, including consideration of non-animal testing approaches where scientifically valid and accepted. Working hands-on with your team, we develop well-structured biological evaluation strategies that support EU MDR, UKCA, and wider global regulatory submissions.
Our goal is to make the biological evaluation process clearer, more proportionate, and better integrated with your overall clinical and regulatory evidence package, so you can move forward with confidence.
What we offer
Biological Safety Evaluation
We prepare Biological Safety Evaluations in accordance with ISO 10993, Risk Management Files and Clinical Evaluation, taking a risk-based approach to assess potential biological hazards. This includes reviewing device materials, contact type, exposure duration, available evidence, and residual risks to determine whether further testing, justification, or documentation is required to support regulatory compliance.
Biocompatibility Strategy and Test Planning
We develop biocompatibility test plans based on device materials, patient contact type, exposure duration, and applicable ISO 10993 requirements. Our approach identifies relevant biological endpoints, suitable test methods, and any supporting rationale needed, helping ensure testing is targeted, proportionate, and aligned with regulatory expectations for your device family.
Gap Analysis and Risk Assessment
We review your existing data against ISO 10993 and FDA expectations to identify any gaps in your biological safety evidence. This includes assessing material information, previous testing, literature, supplier documentation, and device history to determine whether the evidence is sufficient. Where gaps remain, we recommend appropriate testing or provide scientific justifications to support a compliant, defensible assessment.
Regulatory Submission Support
We support regulatory submissions by preparing, reviewing, and refining technical documentation for medical devices. This includes aligning evidence, reports, declarations, and supporting files with applicable regulatory requirements. Our approach helps ensure submissions are clear, complete, and well-structured, reducing avoidable delays and ensuring smoother interactions with regulatory bodies or notified bodies.
Committed to providing high-quality, reliable services.
Our support helps you build a clear, proportionate, and well-justified biological evaluation package. By combining scientific evidence with practical regulatory insight, we help demonstrate device safety, address potential gaps, and support confident submissions under EU MDR, UKCA, and other applicable regulatory frameworks.