CardioMed Device Consultants provides a broad range of regulatory, engineering, and quality assurance consulting services, clinical trial services, and regulatory department training services to meet your needs. Although we focus on cardiovascular and general hospital devices, our education, experience, and broad knowledge of FDA’s processes and requirements have proven valuable for manufacturers of medical devices intended for various medical specialty areas. Whether large or small, numerous companies have found our services invaluable to their medical device development and regulatory strategy processes.
Services
Integrated expertise for every part of your device program.
Regulatory, preclinical, clinical and quality consulting from one senior-led team, planned together so your strategy and your evidence line up from the start.
Clinical Trial Consulting
Study design and oversight
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Preclinical Testing Consulting
Test strategy, review and lab recommendations
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Quality Systems & Manufacturing
QMSR, ISO 13485 and inspection readiness
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Regulatory Consulting
Strategy, submissions and FDA meetings
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Not sure where to start?
Tell us about your device and where it stands. We'll recommend the right next step, whether or not it involves us.
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Ready to advance your device program?
Tell us about your device and timeline.