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Decus Core Team

  Decus team gives back to the community at a work day for Habitat for Humanity.

Grace Bartoo, Ph.D., RAC, CBA (click here for resume in PDF format)

President and CEO.  Grace holds a Ph.D. in Bioengineering and an MS in Electrical Engineering from the University of Washington. She completed her undergraduate in Bioengineering at UC Berkeley. She also is certified in regulatory affairs (RAC) and biomedical quality auditing (CBA). Grace has been involved in medical devices for over 25 years, starting as a research engineer in a medical ultrasound company and then transferring into clinical research, regulatory, and quality roles. She was a co-founder of NeoPath, which developed world’s first Pap smear analyzer. She has helped multiple medical device startup companies, first as a partner at the product development consulting firm Instrumentation for Science and Medicine, and for the last five years as the owner of Decus Biomedical.

Marc Bartoo, Ph.D., RAC (click here for resume in PDF format)

Technical Services Manager.  Marc holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemistry from UC Berkeley. Marc started as a research chemist for drug delivery systems at Alza.  After his doctorate, he was a Senior Research Fellow at the University of York in York, England. Marc returned to the biomedical industry about 10 years ago and has been a consultant for clients in the areas of Electronic Stimulators, Drug Delivery, Blood Test, Ultrasound, Imaging Systems and Radio Frequency.  His primary expertise is in design controls, including verification and validation.  Marc is also certified in regulatory affairs (RAC).

Patricia Campbell, CCRA, CSQE (click here for resume in PDF format)

Clinical Affairs Specialist.  Pat is a Certified Clinical Research Associate (CCRA) who holds a B.A. in Organizational Management from Ashford University .  Her experience covers 13 years of Clinical Trial Experience, 7 years of Medical Device Development, 24 years in Computer Programming, and 11 years of Project Management and Management.  Pat has worked as Software Engineering Manager for Fischer Imaging Corporation, Principal Software Engineer for Unisys Corporation and Clinical Operations Manager for MiraMedica. 

Terry Passarotti, MBA CBA (click here for resume in PDF format)

Operations Manager. Terry holds an M.B.A. in Sustainable Management from Presidio School of Management and a B.A. in Chemistry from Wells College. Terry is a Certified Biomedical Auditor (CBA) supporting clients with compliance to FDA CFR as well as EU compliance including ISO 13485, ISO 14971 and IEC 62304. Terry is also responsible for Decus clients' clinical data management projects including case report form and database design, process and procedure development, and study execution. She also participates in regulatory submission projects as needed. In addition to client work, Terry is responsible for Decus operations and finance.

Tav Rotondale, BSE (click here for resume in PDF format)

Quality Assurance Specialist. Tav has worked in new product development in a wide variety of industries over the last 24 years. Over the last 11 years he has worked in the field of nuclear medicine systems and invasive medical devices involving GMP, GLP, and GCP.  He has certification in ISO 14971, ISO 9000/9001, and ISO 14001. He has worked as a design engineer and analyst, project & program manager, risk management leader, change control board signatory for engineering, RA and QA, as the liaison between engineering, manufacturing, and QA, and as a regulatory compliance and QA manager.  Tav has participated in FDA and ISO 13485 audits and conducted numerous internal quality system audits.

Bonnie Wu, MS RAC (click here for resume in PDF format)

Regulatory Affairs Specialist.  Bonnie is certified in regulatory affairs (RAC) in both US and EU regulations.  Bonnie has 10 years of product development experience in biotech industry.  Prior to joining Decus, she held a regulatory position at iScience for two years, and a senior management position at Schering-Plough BioPharma for eight years.  Bonnie received her M.S. in Biochemistry from Miami University and B.S. in Food Engineering from South China Institute of Technology.

Our team is also supported by a number of highly qualified professionals:

bulletSoftware Engineers

bulletBiostatisticians

bulletData Analysts

bulletTechnical Writers

bulletClinical Research Staff

bulletProject Management Support

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