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