ID1071
Toxicology and Biosafety of Medical Device
DVM, PhD, UCPH
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
- Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER)
- Chemical/Toxicological risk analysis and assessment (TRA)
- Toxicology of nanomaterials
- Project, process, and document management
- Literature search and review
- Scientific writing and reporting
- Drafting, editing, and review of templates, SOPs, reports, statements, and papers
- QMS documents: drafting and revisions of Procedures, Instructions, Templates, Forms and Details
- Supplier Change Qualification Assessments
- Design and evaluation of animal studies
- Histological and histopathological imaging evaluation with QuPath
Key results
- Cat. I-III Medical Devices: Biological Evaluation Plans and Biological Evaluation Reports, MDD-MDR transition, and documentation maintenance according to standards and regulations
- Toxicological risk assessment and biosafety of worst case contacting medical devices (implants with long term/permanent contact and externally communicating devices with contact to circulating blood)
- Biological Evaluation of materials and tools used in the manufacture of medical device
- >20 scientific publications and review articles in peer- reviewed journals from 7 years in academic positions (Google Scholar: 843 citations, H-index 11)
- Multiple reviewer assignments for journals such as International Journal of Toxicology, Laboratory Animals, and Comparative Medicine
Software/Standards
- EU (MDD) MDR – transition and merge of biological safety documentation
- ISO 10993 Biological evaluation of medical devices
- ISO 13485 QMS medical devices
- FDA Biocompatibility Guidance
- ISO 13485 (2024, Preventia)
- Chemical Characterization Workshop (2024, NAMSA)
- 2nd Annual European Medical Device Biocompatibility Conference (2024, TT Lifesciences)
Personal Characteristics
Information detective and excellent scientific writer.
Profound understanding of complex biological systems.
Cross-discplinary experience with scientific research, laboratory animal science, medical devices, project management, quality management, scientific dissemination, and higher education teaching and communication.
Detail-oriented, focused, effective, fast learning, and honest approach.
DK Authorization to practice Veterinary Medicine (2011).
Laboratory Animal Science EU Function ABD (FELASA Cat. C) (2011) License.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com