FDA Compliant Medical Software Development

Firmware and software are of increasing importance in today’s medical devices. The ongoing process of technological improvements, including custom medical software development, audits and requirements development, required to meet a specific industry’s requirements and standards can be costly in terms of both time and dollars. The slightest technical miscalculation can manifest into a compromised reputation and worse, a potentially avoidable health threat. This is why we specialize in FDA software validation requirements and perform full medical software audits. For medical device manufacturers, keeping up with regulatory pressures is a persistent challenge—one that can inhibit innovation and market entry.

Our comprehensive experience in FDA software development for medical devices means you get the most up-to-date development technologies, ensuring efficiency and flexibility for future requirement changes. Gaining a competitive edge within this aggressive marketplace mandates efficiency at every stage from design to implementation. To help our clients maintain their market position, we offer continuous technical support and consulting whether creating a whole new system of custom software or reengineering an outdated or problematic system.

• Blood Analyzers
• Infusion Pumps
• Toxicology, Oncology, Ophthalmology & Neurology Diagnostics
• Operating Room Devices
• Medical Image Analysis

Learn more about our experience with custom medical software and firmware development.