– About –

Deanna photo.jpg

Deanna has extensive worldwide regulatory and quality experience in medical devices including class III implantable devices.  She is experienced with ISO 13485 MDSAP, the new MDR, Cybersecurity, and UDI Labeling. She has experience in the areas of ophthalmology, cardiovascular, neurological, diabetes, and wound care. 

She has performed many Investigational Device Exemptions (IDE's/clinical investigations), two original Premarket Applications (PMA) and numerous 510k's. Additionally, she has developed and implemented quality systems to comply with ISO 13485 MDSAP and other worldwide standards.  She has represented firms to the FDA and third party auditors leading Corrective and Preventative action programs, as well as process validation experience. She has her lead auditing certification and has been involved in numerous FDA and Notified Regulatory Body audits representing clients.

She is also versed in design control, having lead design teams from the feasibility to product launch providing team leadership in customer requirements, risk assessments and design transfer.

Deanna has been working in Regulatory Affairs and Quality Assurance for 18 plus years in the medical device industry. Her clients include Fortune 500 as well as mid-size and start-up companies. She holds three engineering degrees. She double-majored at the University of Michigan, Ann Arbor in Mechanical Engineering and Bioengineering and has a master's degree in Biomedical Engineering from the University of Southern California in Los Angeles. 

Deanna is also on the Board of Directors for Juvenile Diabetes Research Foundation where she is the research Information volunteer.