Select Projects

Benefit-Risk Justification:  Provided compliance documentation and support for the European Union Medical Device Regulation (EU MDR), Regulation (EC) No 2017/745, Annex I, General Safety and Performance Requirements (GSPR) 10, including authoring benefit-risk justifications for the presence of a carcinogenic/mutagenic substance.

Compliance Strategy Development:  Met with EU Notified Body (BSI) in support of Notified Body conversion and Medical Device Directive (MDD) to MDR compliance.  Developed a strategy to achieve EU MDR compliance to ISO 10993 and oversaw execution of the strategy for 12+ product lines, ranging from long-term implants to transient contact medical devices, and intact skin contact medical devices to highly invasive medical devices.

Biological Evaluations for Drug/Fluid Administration Sets:  Developed and conducted biological safety evaluation strategies for two unique drug/fluid administration set families (510k/CE approved).  Authored biological safety evaluation plans and reports inclusive of in vivo and in vitro biocompatibility results, chemical characterization evaluations, toxicological risk assessments, material and manufacturing analyses, and justifications for non-testing.

Biological Evaluations Pain Management Kits:  Developed and conducted biological safety evaluation strategies for neuraxial pain management kits (510k/CE approved).  Authored biological safety evaluation plans and reports inclusive of in vivo and in vitro biocompatibility results, chemical characterization evaluations to address drug compatibility, toxicological risk assessments, material and manufacturing analyses, and justifications for non-testing.

Biological Evaluations for Tracheostomy Tubes:  Led biological safety evaluation strategies for breathing gas pathway tracheostomy tubes (CE approved).  Reviewed biological safety evaluation plans and reports inclusive of in vivo and in vitro biocompatibility results, chemical characterization evaluations, toxicological risk assessments, material and manufacturing analyses, and justifications for non-testing.

Biological Evaluations for Implants:  Developed and conducted biological safety evaluations for three metal implants (pre-market approval [PMA] and 510k/CE approved) and one tissue implant (510k/CE approved) and their related delivery system accessories (510k/CE approved).  Authored biological safety evaluations inclusive of in vivo and in vitro biocompatibility results, chemical characterization evaluations, toxicological risk assessments, material and manufacturing analyses, and justifications for non-testing.

Animal Safety and Efficacy Assessment:  Collaborated with clinical team to conduct and utilize large animal safety and efficacy studies (canine, swine) to meet the ISO 10993 endpoints of implantation and hemocompatibility to conserve animals while reducing cost.