Ajit P. Yoganathan, PhD
Principal Consultant
Dr. Ajit Yoganathan is a Principal Consultant at CardioMed Device Consultants and an internationally recognized leader in cardiovascular engineering, biomechanics, and medical…
Read bio →Senior-Led Expertise Across the Full Medical Device Development Lifecycle
CardioMed's consultants bring decades of direct industry and government regulatory experience to every engagement. Your program is led — and executed — by seasoned professionals with firsthand expertise in FDA expectations, complex device development, and cardiovascular device review.
Our Consultants
Principal consultants
Candace F. Cederman, MS
Principal Consultant
Candace Cederman is a Principal Consultant at CardioMed Device Consultants with more than 30 years of experience in medical device regulatory affairs,…
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Chiara Lorenzetto
Principal Consultant
Chiara Lorenzetto is a Principal Consultant at CardioMed Device Consultants with nearly 20 years of experience in medical device and pharmaceutical product…
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Diana Williamson
Principal Consultant
Diana Williamson is a Principal Consultant at CardioMed Device Consultants with extensive experience in medical device development, design controls, and regulatory compliance.…
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Elisa D. Harvey, DVM, PhD
Principal Consultant
Dr. Elisa Harvey is a Principal Consultant at CardioMed Device Consultants and a former FDA branch chief and regulatory program leader. She…
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Kevin Soucy, PhD
Principal Consultant
Dr. Kevin Soucy is a Principal Consultant at CardioMed Device Consultants and former FDA Senior Lead Reviewer with seven years of FDA…
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Lynn Bailey
Principal Consultant
Lynn Bailey is a Principal Consultant at CardioMed Device Consultants with more than 35 years of experience in preclinical research, specializing in…
Read bio →MaiQuyen Nguyen, MS
Principal Consultant
MaiQuyen Nguyen is a Principal Consultant at CardioMed Device Consultants and a former FDA Lead Reviewer with six years of experience in…
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Meagan Fagan, M.S.
Principal Consultant
Meagan Fagan is a Principal Consultant at CardioMed Device Consultants, bringing more than 19 years of experience in medical device development, regulatory…
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Mona M. Advani, MS, MBA
Principal Consultant
Mona Advani is an accomplished medical device regulatory affairs consultant with more than 25 years of experience in U.S. and international regulatory…
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Richard E. Galgon, MD, MS
Principal Consultant
Dr. Rick Galgon is a Principal Consultant at CardioMed Device Consultants, bringing extensive expertise in medical device regulatory affairs, biomedical engineering, clinical…
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Roseita Esfand
Principal Consultant
Dr. Roseita Esfand is a Principal Consultant at CardioMed Device Consultants, bringing more than 20 years of experience in pharmaceutical development, drug…
Read bio →Affiliate Consultants
A specialized network of expert advisors.
Anna Christensen
Affiliate Consultant
Anna Christensen is an Affiliate Consultant with CardioMed Device Consultants and a well-recognized regulatory and quality assurance consultant with more than 12…
Read bio →David Lin, PhD
Affiliate Consultant
Dr. David Lin works with CardioMed Device Consultants as an affiliate consultant. He has over 27 years of pharmaceutical regulatory experience in…
Read bio →Dwight Back, PhD
Affiliate Consultant
Dwight D. Back, Ph.D., has worked in a high-level technical capacity across the spectrum of high tech industries from medical devices to…
Read bio →Gary Binyamin, PhD
Affiliate Consultant
Dr. Binyamin works with CardioMed Device Consultants as an affiliate consultant. He has over two decades of experience successfully bringing therapeutic products…
Read bio →Jennifer Asleson, CBA, CPGP
Affiliate Consultant
Jennifer Asleson is an Affiliate Consultant with CardioMed Device Consultants, focused on sterilization, microbiology, and sterile barrier systems. She brings more than…
Read bio →Lisa Bellincampi, PhD
Affiliate Consultant
Dr. Lisa Bellincampi is an Affiliate Consultant with CardioMed Device Consultants, bringing about 20 years of experience in research and development and…
Read bio →Shira Rosenberg-Tzur
Affiliate Consultant
Ms. Rosenberg-Tzur works with CardioMed as an affiliate consultant, bringing over 20 years of experience in regulatory affairs and quality assurance in…
Read bio →Srin Nagaraja, PhD
Affiliate Consultant
Srin assists medical device companies with mechanical and corrosion assessments of implants for regulatory approval. Experience He spent a decade at the…
Read bio →Steven Opolski, MS
Affiliate Consultant
Steven Opolski is an Affiliate Consultant with CardioMed Device Consultants with almost 30 years of medical device industry experience. He specializes in…
Read bio →Victor Novack, MD, PhD
Affiliate Consultant
Dr. Novack is a Physician Trialist at CardioMed Device Consultants. In addition, he is currently the Head of The Clinical Research Center,…
Read bio →Wolfgang Kainz, PhD
Affiliate Consultant
Dr. Kainz's experience is focused on the safety and effectiveness of medical devices and the safety of humans in electromagnetic fields. This…
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