Risk assessments of materials
The numerous assessments of different materials that through the years have been submitted by TKT to clients and regulatory authorities provides proof of competence, resulting in a favorable outcome for our clients.
Toxicological investigations / advice / categorization / risk assessment of medical devices within the ISO 10993 standards.
Design, procurement and monitoring of biological tests / chemical analysis (e.g. ISO10993-18)
Identification of Allowable limits / Tolerable intake (ISO 10993-17).
Risk assessments, including in silico analysis, of extractables, leachables and degradation products.
Literature reviews, e.g. as part of material characterization, in accordance with ISO 10993: 2009 and ISO 10993: 2018
Literature and database searches according to clients’ specific requirements.