BIOMEDICAL DEVICES

• • Biological evaluation according to ISO 10993-1, based on the individual constituents and intended use (duration and nature of body contact). Assessment of other factors such as manufacturing including sterilization and packaging to mitigate the biological risk

• • Preparation of Biological Evaluation Plan (BEP): identification of tests that are required to assess the biocompatibility of the device; preparation of scientific rationale to address and waive some tests indicated by the standards

• • Biological Evaluation Report (BER): preparation of a document reporting all the results obtained from the tests (chemical, biocompatibility), and scientific information from open literature to support the safety of the device

• • Toxicological Risk Assessment of medical device constituents according to ISO 10993-17:2023, ISO 18562 series, and related standards

• • Based on the new MDR requirements, preparation of an expert opinion to assess any pharmacological action of the ingredients of the substance-based devices

• • As requested by MDR, identification of CMR and ED present in the device or absence declaration

• • Components and material assessment with information from open literature

• • Study monitoring and assistance during the testing phase and contact with the testing facilities

• • Study monitoring and assistance in preparation of BEP and BER in line with FDA requirements, fill out the e-star model

• • Identification of substances that could become classified as CMR and ED in the near future

• • Gap-analysis to understand the tests/analysis that might be missing or need to be implemented (comparing old and latest versions of ISO standards), to be compliant with the MDR requirements

• • Risk assessment of devices containing nanoparticles

• • Regulatory consultancy also available, via third party

BIOTECHNOLOGICAL
SKILLS

We are experts in optimizing biological processes and in creating innovative, customized, and cutting-edge products