Medical device consultants possess a broad understanding of regulatory and compliance requirements. They assist medical device manufacturers’ with complex projects, which often include remediation of design history files (DHF) and Device Master Records (DMR).

In the late 1990s, the FDA recognized that the designs of new products, or changes to, including line extensions to existing products were not well controlled. This led to the Formal Design Control and Design History File (DHF) requirements instituted by the FDA in 1996-1997.

Device history files are a compilation of documents which include Design and Development Planning, Design Input, Design Output, Design Reviews, Design Verification, Design Validation testing, Design Transfer, and Design Changes. Whereas, the output of the design controls process is the Device Master Record (DMR).

Medical device consultants ensure independent review and remediation of product design, manufacturing, labeling, packaging, and sterilization documentation to ensure product safety and patient efficacy. Companies often use medical device consultants to alleviate the demand that remediation activities have on their own full-time staff.

Our solutions are comprehensive and encompass the full spectrum of quality, compliance, and validation services. Unlike any other service provider, our core team consists of engineers who work in industry and specialize in identifying and placing the right people for your project.