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Healthcare ISV’s and Medical Device manufacturers face tremendous challenges and big opportunities. Price pressures, growing competition and constantly changing reimbursements require companies to be nimble and cost-effective. Key success factors include time-to-market, cost, ability to integrate with other systems, compliance and certification and constant product innovation. Symphony has extensive experience in working with companies that are governed by federal regulations. Symphony’s processes are audit for 21 CFR Part 820 (QSR) standards and comply with Good documentation practices (GDP) required by the regulations. Through our matured processes, Symphony has provided significant cost savings and decreased time to market. Our client’s derive major benefits from out flexible engagement models that are designed to not only our project requirements but also as financial requirements.
- Product Development: Symphony’s seasoned team of healthcare product experts has the depth and breadth of experience to meet your product development objectives. We have helped our clients develop and bring to market systems ranging from anesthesia management systems to state-of-the-art diagnostic imaging technologies. Our processes follow CSV and 21CFR Part 11 compliance regulations. Click here for more information on product development
- Quality Assurance: A key trend among health IT companies is the deployment of external independent quality assurance to increase the quality, reduce defects and maintain the integrity of product releases. Several healthcare ISVs have leveraged Symphony's Quality Center of excellence to perform stringent product testing and quality assurance. Besides functional testing, Symphony assists its clients in performing scalability testing, interoperability testing and usability testing. Symphony’s quality management systems meets the requirements of ISO 13485:2003, ISO 9001:2000, and 21 CFR Part 820 (QSR) standards.
- Compliance: Symphony has assisted several large healthcare ISVs comply with healthcare industry standards. Some of recent engagements include CCHIT compliance of a leading EMR application, CCOW compliance for a peri-operating system, DICOM compliance for a hospital information system, product enhancement to meet CCHIT certification criteria and HCPCS compliance of a care management system. Symphony also provided strategic consulting services for federal agencies and healthcare entities to migrate systems and processes from ICD-9 to ICD-10.
- Integration: Symphony has extensive experience in integrating various components of healthcare technologies, including EMRs, lab information systems, Business Intelligence and analytics solutions, RIS and PACS Systems, billing systems and hospital information systems. By using best practices and knowledge of standards such as HL7, DICOM, CDA, and technologies such as XML, ANSI SQL, J2EE and.NET. Our staff is certified and very intimate with the design and development of e*Gate, HealthVision, and TCL Programming.
- Verification and Validation: Symphony’s skilled and highly qualified V&V practice offers solution for your product testing need. Our software validation services are highly process driven throughout the product development lifecycle. Our validation engineers work with the client’s processes, or can supplement client processes with Symphony’s processes. Our validation team works with clients in a hands-on, consultative, or training role on areas of expertise including: Verification and Validation SOP Development, V&V Planning, Requirements Management and Traceability, Test Design, Test Case, Test Procedure Development, System, Integration, and Unit Level Testing, Regression Test Planning, Defect/Issue Tracking and Management, User Testing
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