Specifications include, but are not limited to: provide MilTech Regulatory and ComplianceSubject Matter Expertise Services to support project deliverables; 2.1 Service Category A – FDA Subject Matter Expert Services, including tasks such as, but not limited to, the following: Provide regulatory compliance assessment of new medical and other product(s), or product(s) already in production, that require FDA approval. Participate as member of the team asking questions of the current developer Provide input to the process as a piece of the final report delivered by MilTech Provide information and guidance related to FDA policies, procedures, compliance, and enforcement issues Provide information and guidance related to FDA Medical and other Product approval processes including clinical trial expectations Provide other information and assistance as needed to assist with transfer of medical and other solutions from review by the FDA into use by the U.S. government. 2.2 Service Category B – NIOSH Subject Matter Expert Services, including tasks such as, but not limited to, the following: Provide regulatory compliance assessment of new medical and other product(s), or product(s) already in production, that require NIOSH approval. Participate as member of the team asking questions of the current developer. Provide input to the process as a piece of the final report delivered by MilTech. Provide information and guidance related to NIOSH policies, procedures, compliance, and enforcement issues. Provide other information and assistance as needed to assist with transfer of medical and other solutions from review by NIOSH into use by the U.S. government. 2.3 Service Category C – ISO Compliance Subject Matter Expert Services, including tasks such as, but not limited to the following: Provide ISO-compliance assessment of medical and other products either currently in development, or currently in production. Participate as a member of the team asking questions of the current developer or manufacturer of the product. Provide input to the process as a piece of the final report delivered by MilTech. Provide ISO standards information and guidance for medical and other products and processes across a wide range of related applications. Provide ISO audit guidance and assistance.
