An Agile Quality System & SDLC for Regulated IT Deliverables
Regulated software requires more than just code—it demands documented, auditable processes that meet FDA, HIPAA, NIST, and other regulatory standards. NUP provides the complete framework your team needs, ready to integrate into your quality management system.
If your software touches healthcare data, medical devices, government systems, or life sciences research, regulators require proof that you follow documented, repeatable processes. Ad-hoc development isn't acceptable.
FDA, HIPAA, NIST, and ONC all require documented software development processes with audit trails.
When auditors arrive, you need organized documentation proving every decision and verification step.
Documented processes reduce errors, improve quality, and protect against compliance violations.
Many teams struggle to bridge the gap between modern agile development and regulatory compliance requirements. They either:
NUP solves this by providing an agile framework designed from the ground up for regulatory compliance.
A complete, ready-to-use quality system with everything your team needs to build compliant software efficiently
A well-defined lifecycle with clear, simple steps that any team can adopt. No complex methodologies to master—just practical, repeatable processes.
Complete artifact templates for every phase of the lifecycle. From requirements to deployment, every document you need is provided and customizable.
Built-in checkpoints ensure every step is considered, tasks are completed, and quality is verified before moving forward.
Extend and elaborate the process to fit your team's specific needs. NUP grows with your organization's complexity.
Combines agile development speed with the documentation rigor that regulated industries demand. Predictable releases with full traceability.
Every artifact is designed with auditors in mind. Demonstrate compliance easily with traceable, organized documentation.
A structured yet flexible approach that ensures quality and compliance at every phase
Requirements gathering, stakeholder analysis, and regulatory scope definition
Architecture, security design, and compliance mapping to regulatory requirements
Iterative coding with built-in quality gates and documentation
Testing, validation, and compliance verification at every level
Controlled releases with rollback capabilities and change documentation
Ongoing monitoring, updates, and continuous compliance assurance
NUP is designed to satisfy the documentation and process requirements of major regulatory frameworks
Quality System Regulation for medical devices and health software
Health Insurance Portability and Accountability Act compliance
Cybersecurity Framework for critical infrastructure
Office of the National Coordinator for Health IT certification
Federal Risk and Authorization Management Program
Service Organization Control 2 Type I & II compliance
NUP isn't meant to replace your existing QMS—it's designed to integrate seamlessly. We provide the foundation documents and processes that slot directly into your organization's quality infrastructure.
All artifacts can be branded and tailored to match your organization's terminology and structure.
Requirements, design decisions, and verification steps are linked for complete audit trails.
NUP has been used to deliver compliant solutions for healthcare, government, and life sciences clients.