Silke Laugeois spent four years within the biomedical research field before joining Biotronik in 2017, where she was responsible for biological safety for Sponsors’ quality management programs. This included the evaluation of potential biological risks arising from medical devices, biological testing according to ISO 10993, the evaluation of toxicological limits for leachables/extractables and the establishment of documentation for regulatory affairs and internal processes. Silke joined NAMSA in 2019 and continues to contribute to authoring Biological Risk Assessments to support manufacturers’ documentation on the biological safety of marketed or new medical devices.
CORE COMPETENCIES
- Working knowledge of FDA, EU MDD, EU MDR, and other global medical device regulations, ISO 10993 series, and ISO 14971
- Elaborating on regulatory strategies for medical device manufacturers
- Authoring of Biological Safety Evaluations and Risk Assessments according to ISO 10993 and ISO 14971 for submissions to FDA and other regulatory agencies and Notified Bodies (NBs)
- Authoring of Toxicological Assessments for potential leachables/extractables according to ISO 10993-17 and ISO/TS 21726 and other relevant guidelines
- Evaluating and determining biological relevance of unexpected results
- Providing Gap Analyses for biocompatibility-related Standards and Guidelines (ISO 10993 series, OECD, ASTM, FDA) and test reports
- Contributing to the preparation of responses to deficiency letters
- Contributing to the preparation of submission files as support for the Regulatory Affairs Departments
- Providing on-site support to Medical Device manufacturer to remediate Quality Systems failures
- Participating in the training of junior Associates
RECENT PROJECTS
- Update of the Biocompatibility file of a range of prefilled syringes for MDR remediation
- Justification and Selection of representative devices to cover a wide range of contact lenses
- Change Control assessment on an application system for bone cements
- Preparation of a rationale to mitigate positive cytotoxicity test results