Medical Systems

First Consulting has extensive experience in all aspects of Medical Systems development, including embedded software for Class III implantable devices, In Vitro Diagnostic analyzers, and Health Information Systems.
We bring to the project:

• Established processes compliant with FDA 21 CFR Part 820 and ISO 13485
• Requirements based development approach that thoroughly defines the system requirements from the onset
• Structured and thorough verification and validation techniques based on sound software engineering principles
• Engineers experienced in the appropriate technologies.

Industry Expertise

In Vitro Diagnostics - System architecture, software design and development, verification and validation testing, and configuration management for several blood analyzers for major manufacturer of In Vitro Diagnostic equipment. These products range from small desktop instruments with embedded software to large scale laboratory analyzers in chemistry and immunoassay blood analysis and DNA detection.

Implantable Devices - Systems engineering and electrical design for a next generation family of pacemaker and ventricular assist devices.

Health Imaging - Software design and development for a family of products for cardiology imaging for a major manufacturer of Health Imaging equipment.

Health and Lab Information Systems - Design and implementation of Lab System interfaces and tools for diagnostic analyzers. Extensive knowledge of HIPAA implementation.

For more information on how we can assist you on your project, please contact Art Roberts at (585) 387-0302 or aroberts@firstconsultinginc.com.