Medical Device Regulatory Affairs

Meet current regulatory requirements for your medical devices

DiGangi Consulting, LLC manages 510(k) submissions to FDA, along with CE Marking of medical devices and non-medical products.

DiGangi Consulting partners with your technical team to identify product-specific requirements, including safety and effectiveness testing, design file documentation, and other necessary actions to ensure proper regulatory compliance and quickly bring your device to market.

Assistance with other types of regulatory submissions, in the U.S. and abroad. Please inquire about your specific product and needs.

InterAgency Involvement and Resources
The firm is experienced working with other agencies, besides FDA, that may get involved because of the nature of your product. Additionally, the company has relationships with outside technical, legal, and regulatory resources to assist with the process, if the need arises.

Quality System and Technical File Planning

As part of the regulatory process, when you bring your product to market your company will likely need to have a quality system and technical files in-place. DiGangi Consulting, LLC will incorporate these needs in the planning stage.

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