We have extensive experience in all aspects of medical and health systems, including development of Class II/III devices and Health Information Systems, as well as software verification and validation.
FIRST CONSULTING SOLUTIONS
In Vitro Diagnostics
Implemented system architecture, software design and development, verification and validation testing, and configuration management for major manufacturers of in vitro diagnostic equipment, which ranged from small desktop instruments with embedded software to large scale laboratory analyzers. Worked with multidisciplinary teams to ensure that the medical device development complied with design control requirements, and internal policies and procedures. Also developed statistical material for clinical submissions—510(K), PMA, and IDE— to federal regulatory agencies.
Assisted in the systems engineering and design for next generation pacemakers and cardiac support devices.
Assisted in the software design and development of products for a major manufacturer of Health Imaging equipment.
Health and Lab Information Systems
Designed and implemented Lab System interfaces and tools utilizing extensive knowledge of HIPAA implementation.
Independent Verification & Validation
We offer an outsource business model for verification and validation testing. The premise of this service offering is that First Consulting accepts full responsibility for medical device software testing including program management, resource management, project management, test planning, writing of test cases, test execution and notebook creation for FDA submission. Work can be done remotely or co-located at client facilities.