Sigma Biomedical
Sigma Biomedical is a regulatory consulting firm based in Miami, FL, specializing in comprehensive support for medical device product approvals across multiple international markets, including the US, Mexico, and Brazil. With a team of experienced engineers and regulatory experts, the company offers services that cover everything from 510k submissions and product testing to quality management systems implementation.
Drawing on over 30 years of industry experience, Sigma Biomedical aims to streamline the regulatory process, ensuring that clients' products are safe, effective, and compliant with complex regulations. By combining regulatory affairs with engineering and manufacturing compliance, Sigma assists companies in maximizing their return on investment while bringing innovative medical solutions to market more efficiently.
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