Biocompatibility evaluations, planned using ISO 10993-1, generate the objective evidence needed to identify hazards, assess biological risks and determine whether chemical or biological testing is required. This evaluation supports regulatory documentation for FDA premarket submissions (510(k) and PMA), EU MDR technical documentation and other international approvals.
Hohenstein Medical provides ISO 17025-accredited and GLP-compliant testing, along with scientific expertise, to design targeted biocompatibility strategies. With one partner for planning, testing and interpretation, you gain a clear and defensible path to FDA, EU and global market approval.
Biocompatibility evaluates how a medical device interacts with the body, including materials and any manufacturing or sterilization residues that could cause harmful biological responses during intended use.
A complete evaluation confirms that the finished device will not trigger irritation, sensitization or systemic effects. When this work is overlooked or incomplete, patients face preventable biological risks, and manufacturers face regulatory delays, test failures, redesigns and potential market withdrawal.
ISO 10993 requires a risk-based approach to determine what must be tested and what can be justified with existing data. A well-planned biocompatibility program helps build a defensible biological safety case for FDA, EU MDR and global submissions.
Engaging an expert early in development helps you:
Early planning reduces the likelihood of unexpected biological responses, supports predictable timelines and improves the efficiency of the overall evaluation.
We provide GLP-compliant testing that reduces the need for animal studies. Services include:
Understanding which substances may be released from your device materials is essential for FDA, EU MDR and other global submissions. Our GLP-certified, ISO/IEC 17025–accredited lab performs extractables and leachables testing (E&L) with advanced analytical methods to support toxicological risk assessment and biological evaluation.
Device safety extends beyond initial testing. Materials can change over time due to storage, transport or sterilization, which may alter their biological response. As part of a biocompatibility strategy, ageing and shelf-life studies provide evidence that your device will continue to meet ISO 10993 requirements throughout its intended lifecycle.
ISO 18562 provides a clear framework for evaluating the biological safety of breathing-gas pathways in respiratory and inhalation devices.
ISO 18562-1 describes how manufacturers classify gas pathways, review existing data and select the appropriate tests within a risk-management process.
Test Methods of Breathing Gas Pathways:
These methods align with ISO 18562-1 to support FDA, EU MDR and global respiratory-device submissions.
