Genova Technologies’ teams and developers can step in at any stage of your Software Development Lifecycle (SDLC) to help your experts develop safe, effective, and FDA / IEC 62304 compliant medical device products and applications. We are a true Engineering Services company, working closely with you and your team to understand every aspect of your design, development, and testing needs, to help ensure quality Class I, II, and III medical device products and applications.

Genova is ISO 13485 compliant, and its quality systems and practices are compliant with standards IEC 62304, ISO 14971, 93/42/EEC, and CMMI Level 3.

Genova Technologies can help you with any step in the medical device software development lifecycle process, including:

• Full software life-cycle development
• Software verification and validation testing
• Design History File (DHF) Remediation
• Independent medical systems verification/validation to support your submissions
• Unit module testing and integration testing (Black box-White box)
• Waterfall or Agile Scrum processes; including Certified Product Owners and ScrumMasters
• Algorithm development
• Mobile Application Integration