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OUR CASE STUDIES

MEDICAL DEVICES

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.

Implantable Devices - Assisted in the systems engineering and design for next generation pacemakers and cardiac support devices.

Health Imaging - 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 - First Consulting, Inc. offers an outsource business model for verification and validation testing. The premise of this service offering is that First Consulting, Inc. 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.