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REGULATORY/QUALITY MANAGEMENT INFORMATION SOURCE INCORPORATED
AMESBURY, MA, 01913
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Subcontracting experience
1 record from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Defense | SCOPE OF WORK
RQMIS WILL PROVIDE CONSULTANCY SERVICES TO SUPPORT THE PREPARATION, PUBLICATION, AND FDA FOLLOW-UP FOR AN FDA DE NOVO SUBMISSION FOR THE BIOTECHNOLOGY HIGH PERFORMANCE COMPUTING SOFTWARE APPLICATIONS INSTITUTE'S (BHSAI) APPRAISE-HRI SYSTEM. RQMIS WILL PROVIDE GUIDANCE ON CONTENT REQUIREMENTS OF THE DE NOVO SUBMISSION BASED UPON FDA FEEDBACK DURING THE PREVIOUS PRODUCT PRE-SUBMISSION AND THEIR EXTENSIVE EXPERIENCE WITH SUBMITTING DE NOVO REQUESTS BOTH CURRENTLY AND IN THE PAST. BHSAI SHALL PROVIDE THE
SOURCE DOCUMENTATION DESCRIBING THE PRODUCT, DESIGN FEATURES/SPECIFICATIONS, SOFTWARE DOCUMENTATION PER FDA GUIDANCE, RISK MANAGEMENT DOCUMENTATION, VERIFICATION AND VALIDATION TESTING AND PRODUCT LABELLING. RQMIS SHALL SUPPORT THE WRITING OF THE DE NOVO 510(K) SUBMISSION AND PUBLISH FOR FDA REVIEW WITH BHSAI'S APPROVAL. RQMIS SHALL HELP ADDRESS ANY QUESTIONS FROM FDA WITH BHSAI'S SUPPORT. THE OBJECTIVE IS TO SUPPORT GAINING A DE NOVO 510(K) CLEARANCE.
RQMIS SHALL PROVIDE GUIDANCE ON THE SOFTWARE DEVELOPMENT INCLUDING ESTABLISHING A DESIGN CONTROL PROCESS, INCLUDING SOFTWARE DEVELOPMENT THAT IS COMPLIANT WITH FDA REQUIREMENTS. RQMIS SHALL ASSIST IN WRITING THESE PROCESSES AND ALSO PROVIDE GUIDANCE DURING THE SOFTWARE DEVELOPMENT PROCESS TO GUIDE THE PRODUCT DEVELOPMENT TEAM ON THE CONTENT/QUALITY OF DOCUMENTATION THAT SHOULD BE PRODUCED DURING THE DEVELOPMENT PROCESS. THE GOAL OF THESE PROCESSES IS TO ESTABLISH A DEVELOPMENT PROCESS THAT IS COMPLIANT WITH
21CFR820.30 AND WILL SUPPORT A SUCCESSFUL DE NOVO 510(K) SUBMISSION. 5989 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MD Parent award description: MILITARY READINESS RESEARCH SUPPORT SERVICES View parent award on USAspending | — | $27,813 | Dec 6, 2022 | — – — |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Government-sourced data comes from SAM.gov, SBA and USAspending.gov and is attributed to its source. Items marked company-reported were provided by the company and are verified by FedSub only where labeled. FedSub is a private company and is not affiliated with SBA, GSA/SAM.gov, or any government agency.