Design & Development
Manage the complete design and development lifecycle from user needs through design transfer. Maintain full traceability between design inputs, outputs, verification, and validation activities as required by FDA QMSR and ISO 13485.
Part of Design & Development
Regulatory Context
Key Capabilities
What you get with the Design & Development module.
Why It Matters
How Design & Development helps your organisation.
How It Connects
Design & Developmentdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.
Ready to see Design & Development in action?
Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Design & Development works within your specific compliance context.
More in Design & Development
Explore other modules in the Design & Development category.
Design Projects
Organize and track design and development projects with milestone planning, task management, and team coordination. Keep complex product development on schedule while ensuring all design control deliverables are completed and documented.
Device Master Records
Compile and maintain Device Master Records (DMR) containing all specifications, procedures, and instructions needed to manufacture your products. Ensure your DMR is complete, current, and readily accessible for production and regulatory purposes.
Label Masters
Manage master label designs and labeling specifications with version control and regulatory compliance checks. Ensure all product labels, IFUs, and packaging meet UDI requirements and applicable regulatory standards before release to manufacturing.
User Experience & Usability
Plan and document usability engineering activities as required by IEC 62366-1. Manage use specifications, user interface evaluations, and summative usability testing to demonstrate that your devices can be used safely and effectively by intended users.