Medical Device Biocompatibility
ISO 10993-aligned biocompatibility planning and evaluation for 510(k), De Novo, PMA, and EU MDR — scoped to your device's tissue-contact type and exposure duration, so you don't over- or under-test.
Two standards, one cohesive plan.
FDA's medical device biocompatibility expectations have tightened. ISO 10993-1 is the framework, but FDA layers its own specific guidance on top — including chemical characterization, extractables and leachables, and risk-based justifications for skipped endpoints. We design biocompatibility programs that pass both reviews the first time, scoped to your device's contact category and duration so you spend only on the evidence the submission actually requires.
Biological Evaluation Plan
ISO 10993-1 aligned BEP with FDA-specific overlays — the foundation reviewers expect to see referenced throughout the submission.
Endpoint Matrix
Tissue contact type × exposure duration mapped to the specific tests required (cytotoxicity, sensitization, irritation, systemic, genotoxicity, implantation).
Chemical Characterization & E/L
ISO 10993-18 chemical characterization and extractables/leachables strategy — increasingly the route FDA prefers for risk-based justification.
Risk-Based Justification
Where endpoints can be addressed by literature, predicate data, or chemical equivalence rather than new testing — the documentation that defends the choice.
Lab Selection & Oversight
Selection of ISO 17025 / GLP-compliant labs, protocol review, and sponsor-side study monitoring through to defensible reports.
Submission Authoring
Biocompatibility section authoring for 510(k), De Novo, PMA, and EU MDR — structured to anticipate reviewer questions.
Biocompatibility, at the moments that matter.
510(k) & De Novo Submissions
Devices preparing first FDA clearance with materials and contact profile that need defensible biocompatibility evidence.
PMA Programs
Class III devices where biocompatibility integrates with the broader nonclinical package.
EU MDR Alignment
Devices marketed in or moving to the EU, where MDR alignment runs alongside FDA evidence.
Material or Design Changes
Existing products undergoing material substitution, sterilization changes, or design iterations that may re-trigger evaluation.
From contact category to defensible submission.
Device Review
Understand materials, contact type, duration, and clinical use.
Pathway & Endpoints
Map the FDA pathway and the endpoint matrix it requires.
Test & Characterize
Lab selection, protocol design, and sponsor-side oversight.
Submission Authoring
Biocompatibility section authored to anticipate reviewer questions.
Standards we work in.
Book a biocompatibility review.
A focused engagement that maps your contact category to the right endpoint matrix — before you commission unnecessary studies.
Biocompatibility Pathway + Risk Register Sprint
- Biological Evaluation Plan against ISO 10993-1 and FDA expectations
- Endpoint matrix tied to your specific device profile
- Chemical characterization & E/L strategy where applicable