Sigma Biomedical is a leading regulatory consulting firm specializing in medical device product approvals for the US FDA and various international markets. With a team of experienced engineers and scientists, they provide comprehensive services in regulatory affairs, engineering compliance, and quality management systems implementation, ensuring efficient and cost-effective product development and testing.
With over 30 years of expertise, Sigma Biomedical offers assistance in scientific and engineering projects, product testing and validation, as well as compliance with complex FDA and international regulations. Their goal is to help companies achieve timely product approvals, maximizing return on investment and ensuring compliance throughout the entire development process.
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