CardioMed Device Consultants

CardioMed Device Consultants

Medical Equipment Manufacturing

Edgewater, MD 620 followers

About us

Success in the rapidly changing and highly competitive world of medical devices demands people with the right experience and expertise. Errors in device design, test methodology, and regulatory strategy lead to costly delays.   At CardioMed Device Consultants, we are dedicated to working with the medical device and related industries to help bring safe and effective products to the market in a timely and efficient manner.  Our professionals have extensive regulatory, engineering, and clinical experience, as well as ties with the U.S. Food and Drug Administration (FDA), the medical device consulting and testing industry, the medical community, and voluntary standards development organizations.   We are a focus-driven company.  We keep our fingers on the pulse of the rapidly changing and increasingly complex medical device regulatory environment, which enables us to serve you better and ensure a rapid, smooth pathway to the market for your product.  In short, whether you are a large or small medical device manufacturer, you can count on us to help you achieve your product development and marketing goals.

Industry
Medical Equipment Manufacturing
Company size
2-10 employees
Headquarters
Edgewater, MD
Type
Privately Held
Founded
2003
Specialties
Regulatory Consulting Services, Pre- Clinical Consulting Services, Clinical Trial Services, Quality Systems Consulting Services, and Customized Training Programs

Locations

  • Primary

    3168 Braverton Street

    Edgewater, MD 21037, US

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  • GOSB Technopark, Kemal Nehrozoglu Cad.

    Production Building 2, Unit 1

    Gebze, Kocaeli 41480, TR

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Employees at CardioMed Device Consultants

Updates

  • CardioMed is thrilled to participate in #TCT2024. We invite you to stop by Booth #2723 or join us for these sessions. We look forward to seeing you there!   Sunday, October 27, 11:00am – Which Nonclinical Testing Needs Repeating When Iterating Your Device? Factors to Consider. Wednesday, October 30, 9:15am – FDA Townhall 6: Open MIC with the FDA: All Your (General and Specific) Questions Answered   Sunday, October 27, 2:00pm – It’s Not Just the Implant and the Implant Site: Key Considerations in Investigations of Delivery Pathway and Downstream Effects   #TCT2024 #cardiovascular #medicaldevice #medtech

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  • CardioMed is excited about the upcoming TCT Conference in Washington, DC October 27-30. Both Dr. Semih Oktay and Dr. Jasmine Patel are faculty members at the conference this year.   Dr. Semih Oktay will be participating in the following sessions: Sunday, October 27, 11:00am – Which Nonclinical Testing Needs Repeating When Iterating Your Device? Factors to Consider. Wednesday, October 30, 9:15am – FDA Townhall 6: Open MIC with the FDA: All Your (General and Specific) Questions Answered   Dr. Jasmine Patel will be participating in the following session: Sunday, October 27, 2:00pm – It’s Not Just the Implant and the Implant Site: Key Considerations in Investigations of Delivery Pathway and Downstream Effects   Please stop by these sessions to say hello. We look forward to seeing you there.

  • Semih Oktay, President and Founder of CardioMed will be speaking at the that FDA/MDIC Symposia on Computational Modeling & Simulation (CM&S, #ModSim2024) on April 15-17 in Washington DC. Discover the latest technological advancements, state-of-the-art use of CM&S for clinical and non-clinical applications, case studies on assessing model credibility, use of CM&S for medical device evidence generation, and key regulatory updates. The event will kick off with training sessions on model credibility assessment and reporting of CM&S evidence, led by industry and FDA experts. Learn more and register: www.mdic.org/ModSim2024 #CardioMed #FDA #regulatoryaffairs #medtech #simulation #modelling #insilico #medicaldevice

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