cardiomedllc.com

CardioMed Device Consultants

President & Founder. Quality Systems Consulting Services. We are proud of our organization. H Semih Oktay, PhD. Elisa D. Harvey, DVM, PhD. Mona M. Advani, MS, MBA. Stephen L. Hilbert, PhD, MD. Wenda C. Carlyle, PhD. Richard E. Galgon, MD, MS. What our clients are saying. Li" data-cycle-auto-height="container" data-cycle-prev="#testimonial-prev" data-cycle-next="#testimonial-next". Medical Device Company, Israel,. Medical Device Company, India,. Medical Device Company, West Coast, US,. Edgewater, MD 21037.

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CardioMed Device Consultants | cardiomedllc.com Reviews

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President & Founder. Quality Systems Consulting Services. We are proud of our organization. H Semih Oktay, PhD. Elisa D. Harvey, DVM, PhD. Mona M. Advani, MS, MBA. Stephen L. Hilbert, PhD, MD. Wenda C. Carlyle, PhD. Richard E. Galgon, MD, MS. What our clients are saying. Li data-cycle-auto-height=container data-cycle-prev=#testimonial-prev data-cycle-next=#testimonial-next. Medical Device Company, Israel,. Medical Device Company, India,. Medical Device Company, West Coast, US,. Edgewater, MD 21037.

<META> KEYWORDS

1 about us

2 honorary vp engineering

3 principal consultants

4 affiliate consultants

5 office staff

6 partnerships

7 services

8 regulatory consulting services

9 pre clinical consulting services

10 clinical trial services

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CardioMed Device Consultants | cardiomedllc.com Reviews

https://cardiomedllc.com

President & Founder. Quality Systems Consulting Services. We are proud of our organization. H Semih Oktay, PhD. Elisa D. Harvey, DVM, PhD. Mona M. Advani, MS, MBA. Stephen L. Hilbert, PhD, MD. Wenda C. Carlyle, PhD. Richard E. Galgon, MD, MS. What our clients are saying. Li" data-cycle-auto-height="container" data-cycle-prev="#testimonial-prev" data-cycle-next="#testimonial-next". Medical Device Company, Israel,. Medical Device Company, India,. Medical Device Company, West Coast, US,. Edgewater, MD 21037.

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cardiomedllc.com

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H. Semih Oktay, PhD | CardioMed Device Consultants

http://www.cardiomedllc.com/consultant/h-semih-oktay-phd

President & Founder. Quality Systems Consulting Services. President & Founder – H. Semih Oktay, PhD. Semih Oktay is the President and founder of CardioMed Device Consultants. Prior to founding CardioMed, he was Vice President of Regulatory Affairs and Engineering at MicroMed Laboratories, Inc (Petaluma, CA). In this capacity, Dr. Oktay provided engineering and regulatory consulting services to the medical device and related industries, and managed MicroMed’s east-coast office.

2

About Us | CardioMed Device Consultants

http://www.cardiomedllc.com/about-us

President & Founder. Quality Systems Consulting Services. In addition, CardioMed Device Consultants has incorporated an expanding group of Affiliate and Clinical Services Consultants with extensive experience in regulatory affairs and quality assurance from an industry perspective. This addition gives CardioMed Device Consultants a full spectrum team of professionals fully capable of addressing the multitude of needs of the medical device and related industries. Quality Systems Consulting Services.

3

Resources | CardioMed Device Consultants

http://www.cardiomedllc.com/resources

President & Founder. Quality Systems Consulting Services. US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Office of Device Evaluation (ODE). Office of Combination Products. Office of Orphan Products Development. Medical and Professional Societies. American College of Cardiology. The Society for Cardiac Angiography and Interventions. The American Society of Mechanical Engineers. Association for the Advancement of Medical Instrumentation (AAMI).

4

Clinical Trial Services | CardioMed Device Consultants

http://www.cardiomedllc.com/services/clinical-trial-services

President & Founder. Quality Systems Consulting Services. The CardioMed Device Consultants Clinical Trial Services Team is driven by the mission to combine academic rigor with maximum flexibility in the planning and execution of high quality, cost-efficient clinical trials. From the start to the end of your clinical trial, our support incorporates local cultural and regulatory practices, while meeting international Good Clinical Practice standards and client objectives. Vendor selection and due diligence.

5

Stephen L. Hilbert, PhD, MD | CardioMed Device Consultants

http://www.cardiomedllc.com/consultant/stephen-l-hilbert-ph-d-m-d

President & Founder. Quality Systems Consulting Services. Stephen Hilbert, PhD, MD. Stephen Hilbert is a Principal Consultant at CardioMed Device Consultants. He provides preclinical, clinical, and explant pathology consulting services for the medical device industry, specializing in the area of cardiovascular medical devices, particularly pediatric cardiac surgical and cardiac circulatory support devices. Dr. Hilbert offers extensive scientific expertise to assist at every step of the device...

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dyadsystems.com

DYAD Systems, LLC – Our Partners

http://www.dyadsystems.com/team-2/partners

Data Management & Biostatistics. Project Management & Study Monitoring. Phase IV Project Rescue. Assists clinical researchers pursuing FDA and worldwide approvals by providing comprehensive and cost-effective monitoring, auditing, training, and consulting services. LLC is a specialty cardiovascular, quality assurance, regulatory, and clinical consulting firm that helps to bring safe and effective medical devices to the market.

srk-consulting.com

SRK-Consulting, LLC.

http://www.srk-consulting.com/about_us.php

Quality Chemistry, manufacturing. It's time to call an expert. Dr Koepkes Curriculum Vitae. Dr Steven Koepke (president and founder) was originally trained as a physical organic chemist, spent 12 years with the National Cancer Institute at the Frederick Cancer Research Facility (NCI-FCRF) as a researcher and progressed into the regulatory world first at the Environmental Protection Agency and later at the Food and Drug Administration. A renowned medical device firm.

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studio4130 | CardioMed Device Consultants

http://www.studio4130.com/portfolio/cardiomed-device-consultants

CardioMed Device Consultants is a Baltimore-based company that works in regulatory affairs and offers an industry perspective on quality assurance. The company’s previous site, though functional, had become outdated. The design and technology weren’t up to the task of highlighting the company’s consulting role in medical device development, evaluation, and review.

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CardioMed Device Consultants

President & Founder. Quality Systems Consulting Services. We are proud of our organization. H Semih Oktay, PhD. Elisa D. Harvey, DVM, PhD. Mona M. Advani, MS, MBA. Stephen L. Hilbert, PhD, MD. Wenda C. Carlyle, PhD. Richard E. Galgon, MD, MS. What our clients are saying. Li" data-cycle-auto-height="container" data-cycle-prev="#testimonial-prev" data-cycle-next="#testimonial-next". Medical Device Company, Israel,. Medical Device Company, India,. Medical Device Company, West Coast, US,. Edgewater, MD 21037.

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