Design & Development
Walk through design projects and the full design control lifecycle in MoniDoseQMS — from design input and output to verification, validation, transfer, change control, and labeling, all aligned with FDA 21 CFR 820.30, EU MDR, ISO 13485, and IEC 62304.
When you have a product, you need design control. MoniDoseQMS gives you a structured design and development lifecycle — from initial concept through to manufacturing transfer — so your regulatory pathway is built in from the start.
What you'll learn
- 1
Create a design project
Define the project type (new product development, design change, product redesign, platform development, technology transfer), classification, team, timeline, and regulatory requirements.
- 2
Project dashboard
See project ID, name, product, phase, status, progress, and start date. Search and filter across all your design projects.
- 3
Design phases & best practices
Plan concept development, design development, verification, and validation. Built-in best practices: define your project clearly, establish the regulatory pathway up front, and set realistic timelines.
- 4
Regulatory references
Aligned with FDA 21 CFR 820.30 (Design Controls), EU MDR Article 10, ISO 13485, ISO 14971 (Risk Management), and IEC 62304 (Medical Device Software).
- 5
Design input
Document what your product needs to achieve — requirements, specifications, and user needs. Select the project, add a custom ID, and link to supporting documents.
- 6
Design output
Record the results of your design work. The output must satisfy the input requirements — this traceability is built into the workflow.
- 7
Design verification
Verify that the output meets the input. If they don't match, there's a problem to fix. Assign team members to review and create tasks for follow-up.
- 8
Design validation
Confirm the final product meets user needs and intended use. Compatible with MDR and FDA requirements.
- 9
Design transfer, changes & labeling
Transfer to manufacturing, track any design changes through change control, and manage labeling and instructions — the seven steps of the design lifecycle, all in one place.
Free tools to get started
Not sure about your product classification or regulatory pathway? Use the free tools on monidoseqms.com — the Regulatory Guide, Classification Wizard, and Startup Launchpad — no sign-up required.