Providing Technical and Business Computing Solutions
Jove Technologies, LLC is staffed by experienced, seasoned and dedicated Professionals trained in the most modern software development processes. These include ASQ CSQE (Certified Software Quality Engineer) training, Hazard Analysis (ISO 14971-1) and FDA (21 CFR 820) guidelines for Medical Device Management and Design controls. Our processes support the FDA Guidence for 510k and Pre Market Approval (PMA) submittals to provide for ease of regulatory approval.
We also comply with the ANSI/AAMI 62304:2006 standard for Medical Device Software Development and participated in the development of this standards foundation standard ANSI/AAMI SW68:2001.
We have a working knowledge of EN/IEC 601-1-4.
Jove Technologies, LLC staff utilizes the Software Engineering Institute CMMI process model for Software Processes.