Medical devices

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.

For further information and requests for quotations, please use our contact form, or contact any of our consultants.

Medical devices