At MedQAIR, we are excited to partner with Full Spectrum Software, a trusted name in healthcare and medical device software development, located in the USA, New England.
Full Spectrum brings longtime expertise in building high-quality, secure, and scalable healthcare software solutions. Their proven track record across complex medical technologies ensures clients benefit from state-of-the-art software development, including full IEC 62304* compliance at every step.
*IEC 62304 is an international standard that defines the software development lifecycle requirements for medical device software
MedQAIR complements this technical & validation expertise with regulatory leadership across EU MDR, IVDR, and emerging AI regulations. The MedQAIR team specializes in helping MedTech and Digital Health companies navigate EU, US, and other major markets.
Full Spectrum and MedQAIR combine strong software and AI engineering with regulatory know-how, giving innovators a clear, practical path from development to faster and seamless market access.
End-to-End Expertise: From early system design to regulatory approval and market launch, clients benefit from working with a coordinated technical and regulatory team.
Faster Time to Market: With both engineering and regulatory experts working together from day one, projects move faster through development, validation, and regulatory filing in the EU & USA. Early compliance planning minimizes market entry delays.
Reduced Compliance Risks: Every solution is developed with IEC 62304 and relevant global regulatory safety and cybersecurity standards (ISO/IEC) and regulations (EU MDR, IVDR, FDA) in mind. This reduces the risk of costly redesigns, regulatory rejections, or non-conformities.
Broad Technical Coverage: Whether it’s stand-alone medical device software (SaMD), medical device software enabled by AI/ML (AI-SaMD), software for healthcare purposes or embedded software components (SiMD), clients benefit from Full Spectrum’s multi-platform technical skills combined with MedQAIR’s understanding of regulatory nuances for each technology type.
Global Regulatory Reach: MedQAIR provides regulatory support for the EU, US, and other regions, including services for Economic Operators and importers.
Focus on Medical AI Compliance: With the rise of AI in healthcare, compliance is becoming increasingly complex. Our partnership ensures that AI/ML-enabled medical devices and digital health applications meet the upcoming European AI Act requirements and the pending FDA’s requirements, as well as existing device regulations.
De-Risked Innovation for Startups and Enterprises: Both early-stage startups and established MedTech companies can innovate confidently, knowing they are backed by a team that understands both technical challenges and regulatory hurdles, and knows how to overcome them.
Fully Integrated IEC 62304 Development: Software development is carried out under a rigorous IEC 62304 framework, ensuring that products are safe, effective, and auditable for regulatory submissions.
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