Add Your Heading Text Here

Normes du secteur

Aligned with the standards
your industry runs on

See how Modern Requirements4DevOps maps directly to the controls, features, and evidence that leading compliance frameworks require — all inside Azure DevOps.

SOC2 ISO 9001 ISO 9000 ISO 26262 CFR Part 11 ISO 13485 ISO 14971 ISO 17491 ASPICE

Standards Library

Learn how MR4DevOps aligns with popular standards

Practical guides and references for managing compliance across the frameworks regulated teams depend on every day.

📘

ISO 26262

Gérer la conformité à la norme ISO 26262 en tenant compte des exigences actuelles

Easily manage ISO 26262 compliance while accelerating your development cycle.

🚗

ASPICE

Gérer la conformité ASPICE face aux exigences actuelles

Managing ASPICE compliance with Modern Requirements for automotive software performance improvement.

💊

21 CFR Part 11

21 CFR Partie 11 : Foire aux questions

A 21 CFR Part 11 questions-and-answers blog by Modern Requirements.

🩺

Medical Devices

Facilitate the Medical Device Design Controls with Modern Requirements

Achieve quicker compliance, shorter development cycle times, and faster value delivery.

⚙️

ISO 17491

Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Comply with ISO 17491 in an automated and efficient manner.

🏅

ISO 9001:2015

Modern Requirements est certifiée ISO 9001:2015

We are committed to quality assurance and exceeding customer expectations.

At a Glance

Standards we cover

Jump straight to the compliance matrix for any framework below.

SOC2
General ↓ ISO 9001
General ↓ ISO 9000
General ↓ ISO 26262
General ↓ CFR Part 11
Medical ↓ ISO 13485
Medical ↓ ISO 14971
General ↓ ISO 17491
General ↓ ASPICE
Automotive & Manufacturing ↓

Tableau de conformité

Every requirement, mapped to a feature

For each standard: the relevant feature area, what it demands, and the Modern Requirements4DevOps capability that delivers it.

Standard

SOC2

Généralités

This is a standard for service organizations that handle customer data. SOC2 requires that organizations establish and maintain a system of controls to ensure the confidentiality, integrity, and availability of customer data. Requirements management is an important part of these controls, as it ensures that customer requirements for data handling and protection are met.

Relevant feature	Feature description	MR4DevOps feature
Contrôle d'accès	Access controls to ensure that only authorized users can access data. Access controls should be in place to ensure that only authorized individuals are granted access to view or modify requirements or other sensitive data.	Smart DocsCoPilot4DevOps
Recueil des besoins	Ability to gather and document requirements from stakeholders, including identifying the needs and expectations of the system or service under review.	Smart DocsFAQ
Gestion des exigences	Ability to manage and maintain the requirements throughout the development process, including version control, change management, and approval workflows.	VersioningImpact AssessmentApproval
Traçabilité	Ability to establish and maintain traceability between requirements and other project artifacts, such as design, testing, and documentation.	Matrice de traçabilité
Essais	Ability to design and execute tests to verify that the system or service under review meets the requirements and specifications.	Centre de tests
Documentation	Ability to document the requirements, design, testing, and other project artifacts in a clear and concise manner.	Smart DocsSimulationSmart ReportsSmart NoteEmail
Sécurité	Ability to ensure the security and confidentiality of the requirements and other project artifacts, as well as the system or service under review.	Security and Access Control
Collaboration	Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts.	Smart DocsSimulationSmart ReportsSmart NoteEmailReview
Audit	Audit logging to record any changes made to requirements. Audit logs should be maintained to provide an audit trail and flag all changes made to requirements, including who made the change and when it was made.	Traceability MatrixReview
Rapports	Reporting capabilities to provide evidence of compliance. The requirements management tool should be able to produce reports that provide evidence of compliance with SOC2, such as reports on access controls or audit logs.	Rapports intelligents

Standard

ISO 9001

Généralités

This is an international standard for quality management systems. It requires that an organization establish a process for managing its requirements and ensure that they are met throughout the product or service lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Traçabilité	Possibilité de retracer l'origine des exigences.	Matrice de traçabilité
Gestion du changement	Capacité à suivre et à gérer les modifications apportées aux exigences.	VersioningImpact AssessmentApproval
Contrôle de version	Possibilité de suivre l'historique des versions des exigences.	VersioningImpact AssessmentBaseline
Gestion des données de référence	Capacité à gérer et à suivre les exigences approuvées.	Référence
Analyse des besoins	Capacité à analyser et à valider les exigences.	Analyse des besoins
Exigences Collaboration	Capacité à collaborer et à partager les exigences.	Smart DocsSimulationSmart ReportsSmart NoteEmail
Rapports sur les exigences	Capacité à générer des rapports sur les besoins.	Rapports intelligents

Standard

ISO 9000

Généralités

ISO 9000 requires that organizations establish a process for managing their requirements and ensure that they are met throughout the product or service lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Exigences documentées	The organization must establish and maintain documented requirements for its products or services, including those related to quality.	Smart DocsSmart NoteEmail
Analyse des exigences	The organization must review the documented requirements before they are finalized to ensure that they meet the customer's needs.	ReviewApproval
Validation des exigences	The organization must validate the requirements to ensure that they are complete, correct, and unambiguous.	FAQCoPilot4DevOpsReviewApproval
Modifications des exigences	The organization must have a process in place for managing changes to the documented requirements.	BaselineVersioningImpact Assessment
Traçabilité des exigences	The organization must establish and maintain traceability between the requirements and the product or service design and development stages.	Traceability MatrixCoverage Analysis
Vérification des exigences	The organization must verify that the product or service meets the documented requirements.	Test HubReviewApproval
Validation des exigences	The organization must obtain customer acceptance of the product or service in accordance with the documented requirements.	Test HubReviewApproval

Standard

ISO 26262

Généralités

ISO 26262 requires that organizations establish a process for managing the safety requirements of their systems, including the management of safety requirements throughout the development lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Traçabilité	Ability to trace requirements and their implementation throughout the development process.	Matrice de traçabilité
Gestion des données de référence	Ability to manage multiple versions of requirements and their associated artifacts.	Référence
Gestion du changement	Ability to manage changes to requirements and associated artifacts throughout the development process.	Change ManagementVersioningImpact Assessment
Examen et approbation	Ability to review and approve requirements and associated artifacts prior to implementation.	ReviewApproval
Validation des exigences	Ability to validate requirements and ensure they are complete, consistent, and unambiguous.	FAQCoPilot4DevOpsReviewApproval
Réutilisation des exigences	Ability to reuse requirements across multiple projects or products.	Réutilisation des exigences
Hiérarchisation des exigences	Ability to prioritize requirements based on their importance and impact on the system.	Hiérarchisation des exigences
Rapports sur la traçabilité des exigences	Ability to generate reports that show the traceability of requirements and their implementation throughout the development process.	Analyse de la traçabilité
Analyse de l'impact des changements apportés aux exigences	Ability to analyze the impact of changes to requirements on the system and its associated artifacts.	Analyse d'impact

Standard

CFR, partie 11

Médical

This is a regulation that governs electronic records and signatures in the pharmaceutical and medical device industries. CFR Part 11 requires that organizations manage their requirements for electronic records and signatures and ensure that they are accurate, complete, and secure.

Relevant feature	Feature description	MR4DevOps feature
Documents électroniques	Ability to manage electronic records in a secure, reliable, and auditable manner.	Electronic Records Management
Signatures électroniques	Ability to capture and manage electronic signatures in a secure, reliable, and auditable manner.	Signatures électroniques

Standard

ISO 13485

Médical

ISO 13485 requires that organizations establish a process for managing the requirements for their medical devices and ensure that they are safe, effective, and meet regulatory requirements.

Relevant feature	Feature description	MR4DevOps feature
Gestion des risques	Risk management capabilities to identify and manage risks related to medical device requirements. The tool should provide risk management capabilities that allow risks related to medical device requirements to be identified and managed.	Smart DocsBaselineRequirements ReuseTraceability AnalysisMatCal
Traçabilité	Ability to trace requirements and their implementation throughout the development process.	Matrice de traçabilité
Conception et planification du développement	Ability to plan and manage the design and development process, including requirements management and verification.	SimulationDiagrammingUsecase
Spécifications techniques	Ability to capture and manage requirements and input from stakeholders and other sources.	FAQEmail
Résultats de conception	Ability to manage design output and ensure that it meets all applicable requirements and specifications.	Centre de tests
Vérification et validation de la conception	Ability to verify and validate the design to ensure that it meets all applicable requirements and specifications.	ReviewApproval
Modifications de conception	Ability to manage changes to the design throughout the development process, including their impact on other requirements and specifications.	BaselineVersioningImpact Assessment
Contrôle des documents	Ability to manage documents and records associated with the product or service in a controlled and auditable manner.	Smart DocsSmart NoteSmart Reports
Gestion des fournisseurs	Ability to manage suppliers and ensure that they meet all applicable requirements and specifications.	Gestion des fournisseurs
Formation et compétences	Ability to provide training and ensure the competence of personnel involved in the design, development, and production or service delivery process.	ReviewApproval
Gestion des documents	Document management capabilities to manage documentation related to medical device requirements: the tool should provide document management capabilities that allow documentation related to medical device requirements to be managed and tracked.	Smart DocsSmart Note

Standard

ISO 14971

Généralités

ISO 14971 requires that organizations establish a process for managing the requirements for risk management and ensure that risks are identified, analyzed, evaluated, and controlled throughout the product lifecycle.

Relevant feature	Feature description	MR4DevOps feature
Gestion des risques	The tool needs to identify and manage risks related to the safety of medical devices throughout the development process, including the use of risk analysis techniques and risk management plans.	Smart DocsBaselineRequirements ReuseTraceability MatrixMatCal
Analyse des risques	Ability to analyze and evaluate risks associated with medical devices, including identifying hazards and assessing their severity and probability of occurrence.	Analyse d'impact
Surveillance post-commercialisation	Ability to monitor and report on the performance and safety of medical devices after they have been released to the market.	Centre de tests
Informations sur la production et la post-production	Ability to manage information related to the production and post-production of medical devices, including changes to the device and any associated risks.	BaselineVersioningImpact Assessment
Contrôle des documents	Ability to manage documents and records associated with medical devices in a controlled and auditable manner.	Documents intelligents
Traçabilité	Ability to trace requirements and their implementation throughout the development process, including the identification of risks and risk control measures.	Matrice de traçabilité
Conception et planification du développement	Ability to plan and manage the design and development process for medical devices, including requirements management and verification.	SimulationDiagrammingUsecase
Spécifications techniques	Ability to capture and manage requirements and input from stakeholders and other sources for medical devices.	FAQEmail
Fonctionnalités de traçabilité	The tool needs to enable the linking of safety requirements to other requirements and work products to ensure that safety requirements are met.	Liaison entre les éléments de travail
Fonctionnalités de reporting	The tool needs to provide evidence of compliance with ISO 14971 by generating reports on risk management activities.	Rapports intelligents

Standard

ISO 17491

Généralités

ISO 17491 specifies a test method for determining the resistance of protective clothing against penetration by chemicals.

Relevant feature	Feature description	MR4DevOps feature
Fonctionnalités de traçabilité	The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.	Matrice de traçabilité
Documentation relative aux exigences	Ability to document requirements in a clear and concise manner.	Smart DocsCoPilot4DevOps
Conception et planification du développement	Ability to plan and manage the design and development process for medical devices, including requirements management and verification.	SimulationDiagrammingUsecase
Fonctionnalités de reporting	The tool needs to provide evidence of compliance by generating reports on risk management activities.	Rapports intelligents
Gestion du changement	Ability to manage changes to project artifacts, including requirements, design, and code.	Référence

Standard

ASPICE

Automotive & Manufacturing

(Automotive Software Process Improvement Capability dEtermination) is an industry-standard guideline for evaluating software development processes.

Relevant feature	Feature description	MR4DevOps feature
Fonctionnalités de traçabilité	The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.	Matrice de traçabilité
Définition des besoins	Ability to identify, collect and document requirements from stakeholders.	FAQEmail
Analyse des besoins	Ability to analyze requirements for consistency, completeness, feasibility, and testability.	ReviewApproval
Documentation relative aux exigences	Ability to document requirements in a clear and concise manner.	Smart DocsCoPilot4DevOps
Gestion des exigences	Ability to manage changes to requirements, including version control and approval workflows.	VersioningApproval
Vérification des exigences	Ability to verify that requirements have been implemented correctly and meet the specified criteria.	Centre de tests
Gestion du changement	Ability to manage changes to project artifacts, including requirements, design, and code.	BaselineVersioningImpact Assessment
Indicateurs et analyse	Ability to collect and analyze metrics related to project progress, quality, and efficiency.	Indicateurs et analyse
Collaboration	Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts.	Smart DocsSimulationSmart ReportsSmart NoteEmailReview
Configuration	The tool needs to control and document changes to software requirements, including who made the changes and why.	Analyse d'impact
Plans de test	Capability to manage work products related to software requirements: the tool needs to provide support for work products related to software requirements, such as test plans and test cases.	Centre de tests

Ready to make your next audit audit-ready?

Book a personalized demo and see how Modern Requirements4DevOps turns regulatory obligations into traceable, audit-ready evidence.

Add Your Heading Text Here

Learn how MR4DevOps aligns with popular standards

Gérer la conformité à la norme ISO 26262 en tenant compte des exigences actuelles

Gérer la conformité ASPICE face aux exigences actuelles

21 CFR Partie 11 : Foire aux questions

Facilitate the Medical Device Design Controls with Modern Requirements

Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Modern Requirements est certifiée ISO 9001:2015

Standards we cover

Every requirement, mapped to a feature

Ready to make your next audit audit-ready?

Connect

Learn