Regulatory consulting
Medical and Health Products

FDA Regulatory Consulting

Sigma Biomedical is a regulatory consulting and contract biomedical engineering firm specialized in the medical device industry in the US. We have successfully prepared and submitted FDA 510(k) submissions for medical device companies seeking to market, sell and distribute medical products in the United States. Sigma Biomedical can help you determine applicable FDA regulations for your type of products, analyze and validate your product compliance with regulations, determine the best cost effective strategy for device approval and registration, and stay in compliance with FDA regulations in terms of product safety, effectiveness and manufacturing operations.

Sigma Biomedical goes beyond traditional regulatory consulting giving you the advantage of an engineering team that also assists in medical product development and testing for safety and compliance. Experienced engineers who understand the product development process will work with your team so the device gets ready for submission efficiently meeting FDA regulations, saving you precious testing time and money.