Catherine joined NAMSA in 2005 and currently manages the European Biological Safety & Validation Team of more than 20 experts based in France, Germany and the UK. She is responsible for the preparation of Biological Risk Assessments, Change Control Assessments and Toxicological Risk Assessments on various medical devices, including orthopedic/dental, vascular, wound healing, general surgery, drug device combinations and other advanced therapies. Prior to her current role, she occupied various roles at NAMSA within laboratory, sales and consulting functions that furthered her expertise in ISO 10993 testing and safety and performance of medical devices through a risk assessment approach.

CORE COMPETENCIES

• Working knowledge of U.S. FDA, EU MDD, EU MDR and other global medical device regulations, ISO 10993 series, and ISO 14971
• Authoring and reviewing Biological Safety Evaluations and Risk Assessments according to ISO 10993 and ISO 14971 for submissions to the FDA, Notified Bodies and other regulatory agencies
• Authoring and reviewing Toxicological Assessments for potential leachables/extractables according to ISO 10993-17 and ISO/TS 21726, and other relevant guidelines
• Evaluating and summarizing Biocompatibility data to ensure compliance with relevant regulatory requirements and standards
• Providing multiple advisory services to manufacturers on Biocompatibility programs and Preclinical performance study designs to support worldwide market approvals
• Serving as Technical Specialist in support of the sales team for qualification of Client requests
• Authoring multiple answers to deficiency letters, particularly on questions related to Biocompatibility and performance study designs
• Managing the European Biological Safety & Validation Team of Biological Safety Scientists and Toxicologists that prepare sterilization/cleaning validation reports and Biological Evaluation Reports, Change Control Assessment reports, Toxicological Risk Assessments, Gap Analyses and expert reports compliant with ISO 10993 and ISO 14971 standards
• Managing Preclinical studies to assess the performance and safety of medical devices according to ISO 10993 standards under GLP conditions
• Authoring several SOPs and harmonized report templates
• Participating in the preparation of ANSM and FDA inspections
• Authorized person for Animal Testing, Level 1
• Former active member of NAMSA’s Ethical Committee 

RECENT PROJECTS

• Answers to FDA deficiencies related to Biocompatibility of a bioresorbable septal occluder implant
• Response developed to ANSM questions regarding Biocompatibility of an auto-transfusion treatment set
• Answers to TÜV SÜD questions on Biocompatibility of a bone cement containing a drug