Biological evaluation assessments

Biological evaluation supports the demonstration of biological safety of a medical device, based on its intended use, nature and duration of body contact, materials, manufacturing processes and available clinical and scientific evidence.

SteriLandBio supports medical device manufacturers in preparing, reviewing and updating biological evaluation assessments throughout the product life cycle, including new product development, material changes, supplier changes, manufacturing process changes, regulatory remediation activities, gap assessments against updated regulatory or standard requirements, and support for the geographical expansion of products.

Our support may include biological evaluation plans and reports, material and process assessments, gap analyses, test strategy definition, toxicological risk assessment coordination, review of chemical characterization and biocompatibility data, and justification of biological safety based on available evidence.

We help companies build biological evaluation files that are scientifically sound, risk-based and aligned with the device nature, body contact, contact duration and applicable regulatory expectations.