Partenaire Microsoft de référence pour la gestion des exigences depuis 2015
Smarter, Safer Product Development for Medical Device & Life Sciences
Manage product development complexity with AI-powered requirements management—connecting design control, risk, and traceability to ensure confident, audit-ready compliance.
Top Challenges in MedTech Development
Achieving True End-to-End Traceability
Maintaining complete, bidirectional traceability across requirements, risks, design outputs, verification, and validation is difficult with disconnected tools—yet essential for quality, safety, and regulatory readiness.
Disconnected Teams and Systems
Engineering, quality, clinical, and regulatory teams often work in different systems, creating gaps, version conflicts, and misalignment that slows decisions and increases rework.
Navigating Evolving Global Regulations
FDA, ISO 13485, ISO 14971, IEC 62304, and EU MDR expectations keep rising. Teams must demonstrate structured processes, consistent documentation, and clear evidence of control across the lifecycle.
Manual, Inefficient Design Control Execution
Managing requirements, risk files, reviews, changes, and DHF creation manually is slow, error-prone, and resource-intensive—making it difficult to scale development or accelerate time to market.
Addressing the Complexity of MedTech Product Development
Support Multiple Product Development Approaches
A flexible platform that adapts to waterfall, V-model, agile, or hybrid processes used across medical devices, diagnostics, and life sciences programs.
Source unique de vérité dans Azure DevOps
Unify requirements, risks, tests, design outputs, reviews, and documentation—keeping every team aligned with complete end-to-end traceability.
Streamline Reviews, Change Management & Documentation
Centralize reviews, version history, and evidence collection to reduce manual effort and keep compliance documentation organized and inspection-ready.
AI-Powered Requirements Intelligence
Accelerate development with AI that enhances requirement clarity, detects gaps, summarizes changes, and strengthens risk and design traceability.
Chosen by the World's Largest Medical Device & Life Sciences Teams
Industry-Leading AI for Requirements & Product Development
Use powerful AI to bring clarity, speed, and intelligence to every stage of product development.
AI Requirements Authoring
Create clear, structured requirements using established engineering practices such as EARS and INCOSE guidelines. Built-in analysis highlights ambiguity, missing conditions, and weak acceptance criteria to improve requirement quality and testability.
Automated Evidence & Documentation
Generate traceability matrices, review histories, validation summaries, and audit-ready documentation directly from live Azure DevOps data—supporting design history records and regulatory documentation.
Compliance Mapping
Maintain traceability between regulatory obligations, system requirements, risk controls, and verification activities. Mapping relationships across development artifacts simplifies audits, inspections, and regulatory submissions.
Risk & Gap Detection
Highlight ambiguous requirements, missing acceptance criteria, incomplete risk controls, and potential safety gaps early in development—helping teams strengthen product quality and reduce risk.
Intelligent Impact Analysis
Understand the downstream effects of change. When requirements are updated, affected design inputs, risk controls, verification tests, and validation activities are identified so teams can manage controlled product changes with confidence.
Context-Aware AI (BYOD)
AI responses are grounded in your internal quality procedures, SOPs, development guidelines, and historical work items, ensuring outputs reflect your organization’s governance and development practices.
Essential Capabilities for MedTech Requirements & Compliance
End-to-End Traceability for Design Controls
Connect user needs, requirements, risks, design outputs, and verification activities in one system to support FDA and ISO-aligned development.
Integrated Risk & Impact Analysis
Link hazards, mitigations, and verification steps with ISO 14971–aligned workflows, and instantly assess the impact of any change across the product lifecycle.
Streamlined Reviews & Digital Signatures
Accelerate design reviews with structured workflows, clear feedback loops, and Part 11–compliant electronic approvals.
Compliance & Documentation Management
Centralize controlled documentation, evidence, and version history—simplifying audit preparation and ensuring consistent, inspection-ready records.
Requirements Quality & Consistency Checks
Improve requirement clarity and reduce downstream defects with automated quality checks that flag ambiguity, incomplete statements, and missing links to risks or tests.
Verification & Test Coverage Integration
Connect requirements to test cases, protocols, and results to ensure full verification coverage and seamless V&V reporting.
Designed for MedTech & Life Sciences Teams
- Requirements & Systems Analysts Gather, structure, and refine user needs and system requirements to ensure clarity, alignment, and complete traceability.
- Systems & Product Engineers Translate requirements into design decisions and maintain end-to-end linkage across hardware and software components.
- Quality Teams Improve design control rigor, manage structured reviews, and ensure product quality through connected documentation.
- Compliance Teams Maintain clear, auditable records aligned with FDA, ISO, and MDR expectations, and ensure teams stay inspection-ready.
- Program & Project Leads Coordinate cross-functional workflows and maintain visibility into risks, changes, and dependencies.
Enterprise-Grade Security and Compliance for Regulated MedTech & Life Sciences Teams
Plateforme certifiée SOC 2 Type II
Ensures strict controls for data handling, access management, change governance, and operational security—supporting teams developing regulated medical devices and life sciences products.
Compliant With Global Medical Device & Life Sciences Standards
Supports FDA 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, EU MDR documentation expectations, and internal quality system requirements with secure data protection, encryption, and audit-ready traceability inside Azure DevOps.
Comment nous persévérons pour vos projets
« Zions a choisi Modern Requirements4 DevOps comme solution idéalement placée pour répondre à nos besoins, tout en ajoutant des fonctionnalités supplémentaires d’exigences. Nous avons rapidement commencé à migrer du contenu de DOORS Next Generation vers la nouvelle plateforme. Nous collaborions chaque semaine et, en conséquence, avons mis en place une migration fluide avec des fonctionnalités supplémentaires de visualisation des exigences. »
« Nous avions déjà choisi Azure DevOps comme solution ALM, donc Modern Requirements semblait être un choix naturel. Après des recherches plus approfondies, la solution convenait parfaitement aux équipes des systèmes, de l’électronique, de la mécanique, du logiciel et d’autres équipes d’ingénierie. Au cours de l’essai de 30 jours seulement, nous avons importé avec succès les exigences existantes, les avons reliées, effectué une révision d’équipe avec l’historique des audits et produit un rapport facile à comprendre conforme à notre QMS. »
Ready to Transform Your Compliance Process?
Join leading medtech companies who trust our platform to deliver safer, compliant products faster.
