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We are expert in the FDA regulations and guidance documents especially in the area of design control compliance and software validation. We are also expert in ISO 13485 and can help with your international conformance needs. We provide third party quality system audits, and we have been recommended by the FDA for third party certification. We understand that thorough knowledge of the regulations, extensive audit experience (conducting and witnessing audits), wide exposure to industry solutions, and a proven history of interfacing with the FDA are essential to providing expert regulatory advice. We have the unique combination of knowledge and expertise in each of these areas. We can cite numerous examples where our strategies have helped companies avoid significant compliance actions.

There are changes in the FDA submission review process. Read Here.

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