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Alfred holds a PhD in Microelectronics Applied to Biology, also known as Bioelectronics. At NAMSA since 2017, his current role as a Biological Safety Scientist focuses on writing and reviewing Biological Evaluation Plans and Reports per ISO 10993-1 and ISO 14971 and Toxicological Risk Assessments per ISO 10993-17. He provides regular trainings on behalf of NAMSA, and helped with the qualification and validation of NAMSA’s chemistry laboratory in Obernburg am Main, Germany.
CORE COMPETENCIES
- Preparing biological evaluation plans/reports and toxicological risk assessments, in compliance with ISO 10993-1, ISO 10993-17, ISO/TS 21726 and ISO 14971 for submissions to the U.S. Food and Drug Administration (FDA), Notified Bodies (NBs), and other regulatory agencies
- Working knowledge of FDA, EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR) and other global medical device regulations and/or biologics regulations, ISO 10993 series, and ISO 14971
- Ensuring biocompatibility studies follow the most recent regulatory requirements
- Performing biocompatibility gap analyses
- Providing ad hoc consulting services on biocompatibility-related topics, including answers to deficiencies and calls with regulatory agencies
- Providing technical advice and guidance to help clients meet regulatory testing requirements
- Providing technical support to laboratory staff
- Providing training sessions to manufacturers in Europe and Asia on behalf of NAMSA Advisory Service Training series, mainly focussed on Biological Evaluation according to ISO 10993-1, Chemical Characterization according to ISO 10993-18 and Toxicological Risk Assessment according to ISO 10993-17
- Serving as Technical Specialist in support of EU account managers for the qualification of medical device manufacturers’ needs
RECENT PROJECTS
- Participated in the CE-marking of several medical devices by ensuring biocompatibility was appropriately evaluated according to current regulatory and normative requirements
- Supported 510(k) submissions of innovative devices (dermal fillers, implants), including exchanges with the FDA
PUBLICATIONS
- Electrical impedance sensor for quantitative monitoring of infection processes on HCT-8 cells by the waterborne parasite Cryptosporidium. Dibao-Dina A et al., Biosensors and Bioelectronics, Volume 66, 15 April 2015, Pages 69-76
- Electrowetting on functional fibers. Dufour R., Dibao-Dina A et al., Soft Matter, Volume 9, Issue 2, 14 January 2013, Pages 492-497