Medical devices must be designed and manufactured to minimize risks to patients, healthcare professionals and end users. Manufacturers are responsible for demonstrating safety and biocompatibility of patient-contacting devices, a requirement that applies broadly, regardless of submission requirements.
A Foundation for Regulatory Compliance
Biocompatibility evaluations, conducted in line with ISO 10993-1, provide the objective data needed to identify hazards, estimate risks and determine the need for biological safety or chemical characterization testing. This evidence is essential for regulatory submissions, including FDA premarket submissions (510(k) and PMA filings), EU MDR technical documentation and other international approvals.
Hohenstein provides ISO 17025-accredited, GLP-compliant testing and scientific expertise to design targeted biocompatibility strategies — giving you one trusted partner for FDA, EU and global market approval.
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.
For ventilators, inhalation devices and respiratory pathways, ISO 18562 offers the recognized framework for assessing biological safety. Testing is performed as part of the risk management process and includes:
