East Coast MedTech Advisors, LLC
Orlando, United States (US) · Health and Medical
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Last verified
May 2026
Overview
East Coast MedTech Advisors, LLC is a leading medical device consulting firm based in Orlando, Florida. We specialize in providing comprehensive Quality & Regulatory services to the medical technology and healthcare industries, helping companies navigate complex FDA and global regulatory landscapes.
Our team of experienced consultants offers a one-stop shop for developing and implementing robust quality management systems compliant with ISO13485, FDA QSR, CMDR, ANVISA, and other international standards. We support clients through every stage of the product lifecycle, from initial strategy development to ongoing compliance audits and remediation planning.
East Coast MedTech Advisors assists companies with Design Controls, Production and Process Controls, CAPA, Risk Management (ISO14971), CE marking, and more. We also provide strategic analysis, business development support, and expert guidance on topics such as 483 remediation, recalls, and regulatory agent representation. We are dedicated to ensuring our clients achieve and maintain regulatory compliance, ultimately bringing safe and effective medical devices to market.
Our team of experienced consultants offers a one-stop shop for developing and implementing robust quality management systems compliant with ISO13485, FDA QSR, CMDR, ANVISA, and other international standards. We support clients through every stage of the product lifecycle, from initial strategy development to ongoing compliance audits and remediation planning.
East Coast MedTech Advisors assists companies with Design Controls, Production and Process Controls, CAPA, Risk Management (ISO14971), CE marking, and more. We also provide strategic analysis, business development support, and expert guidance on topics such as 483 remediation, recalls, and regulatory agent representation. We are dedicated to ensuring our clients achieve and maintain regulatory compliance, ultimately bringing safe and effective medical devices to market.
Contact Details
info@onqconsult.com
Orlando, United States (US)
Founded
2017
Company Type
Sole Proprietorship
Employees
2-10
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