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Industriestandards

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.

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ISO 26262

Verwaltung der ISO 26262-Konformität mit modernen Anforderungen

Easily manage ISO 26262 compliance while accelerating your development cycle.

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ASPICE

Verwaltung der ASPICE-Konformität mit modernen Anforderungen

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

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21 CFR Part 11

21 CFR Teil 11: Häufig gestellte Fragen

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

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Medical Devices

Facilitate the Medical Device Design Controls with Modern Requirements

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

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⚙️

ISO 17491

Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Comply with ISO 17491 in an automated and efficient manner.

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🏅

ISO 9001:2015

Modern Requirements ist nach ISO 9001:2015 zertifiziert.

We are committed to quality assurance and exceeding customer expectations.

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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 ↓

Compliance-Matrix

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

Allgemein

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
Zugangskontrolle	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
Anforderungserfassung	Ability to gather and document requirements from stakeholders, including identifying the needs and expectations of the system or service under review.	Smart DocsFAQ
Anforderungsmanagement	Ability to manage and maintain the requirements throughout the development process, including version control, change management, and approval workflows.	VersioningImpact AssessmentApproval
Rückverfolgbarkeit	Ability to establish and maintain traceability between requirements and other project artifacts, such as design, testing, and documentation.	Rückverfolgbarkeitsmatrix
Prüfung	Ability to design and execute tests to verify that the system or service under review meets the requirements and specifications.	Testzentrum
Dokumentation	Ability to document the requirements, design, testing, and other project artifacts in a clear and concise manner.	Smart DocsSimulationSmart ReportsSmart NoteEmail
Sicherheit	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
Zusammenarbeit	Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts.	Smart DocsSimulationSmart ReportsSmart NoteEmailReview
Wirtschaftsprüfung	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
Berichterstattung	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.	Intelligente Berichte

Standard

ISO 9001

Allgemein

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
Rückverfolgbarkeit	Fähigkeit, Anforderungen bis zu ihrer Quelle zurückzuverfolgen.	Rückverfolgbarkeitsmatrix
Veränderungsmanagement	Fähigkeit, Änderungen an Anforderungen zu verfolgen und zu verwalten.	VersioningImpact AssessmentApproval
Versionskontrolle	Fähigkeit, Versionen von Anforderungen zu verfolgen.	VersioningImpact AssessmentBaseline
Baseline-Management	Fähigkeit, genehmigte Anforderungen zu verwalten und zu verfolgen.	Ausgangsbasis
Anforderungsanalyse	Fähigkeit, Anforderungen zu analysieren und zu validieren.	Anforderungsanalyse
Anforderungen Zusammenarbeit	Fähigkeit zur Zusammenarbeit und zum Austausch von Anforderungen.	Smart DocsSimulationSmart ReportsSmart NoteEmail
Anforderungsberichterstattung	Fähigkeit, Berichte über Anforderungen zu erstellen.	Intelligente Berichte

Standard

ISO 9000

Allgemein

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
Dokumentierte Anforderungen	The organization must establish and maintain documented requirements for its products or services, including those related to quality.	Smart DocsSmart NoteEmail
Anforderungsüberprüfung	The organization must review the documented requirements before they are finalized to ensure that they meet the customer's needs.	ReviewApproval
Anforderungsvalidierung	The organization must validate the requirements to ensure that they are complete, correct, and unambiguous.	FAQCoPilot4DevOpsReviewApproval
Änderungen der Anforderungen	The organization must have a process in place for managing changes to the documented requirements.	BaselineVersioningImpact Assessment
Rückverfolgbarkeit der Anforderungen	The organization must establish and maintain traceability between the requirements and the product or service design and development stages.	Traceability MatrixCoverage Analysis
Anforderungsprüfung	The organization must verify that the product or service meets the documented requirements.	Test HubReviewApproval
Anforderungsannahme	The organization must obtain customer acceptance of the product or service in accordance with the documented requirements.	Test HubReviewApproval

Standard

ISO 26262

Allgemein

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
Rückverfolgbarkeit	Ability to trace requirements and their implementation throughout the development process.	Rückverfolgbarkeitsmatrix
Baseline-Management	Ability to manage multiple versions of requirements and their associated artifacts.	Ausgangsbasis
Veränderungsmanagement	Ability to manage changes to requirements and associated artifacts throughout the development process.	Change ManagementVersioningImpact Assessment
Prüfung und Genehmigung	Ability to review and approve requirements and associated artifacts prior to implementation.	ReviewApproval
Anforderungsvalidierung	Ability to validate requirements and ensure they are complete, consistent, and unambiguous.	FAQCoPilot4DevOpsReviewApproval
Anforderungen Wiederverwendung	Ability to reuse requirements across multiple projects or products.	Anforderungen Wiederverwendung
Priorisierung der Anforderungen	Ability to prioritize requirements based on their importance and impact on the system.	Priorisierung der Anforderungen
Anforderungsrückverfolgbarkeit Berichterstattung	Ability to generate reports that show the traceability of requirements and their implementation throughout the development process.	Rückverfolgbarkeitsanalyse
Analyse der Auswirkungen von Änderungen an Anforderungen	Ability to analyze the impact of changes to requirements on the system and its associated artifacts.	Folgenabschätzung

Standard

CFR Teil 11

Medizinisch

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
Elektronische Aufzeichnungen	Ability to manage electronic records in a secure, reliable, and auditable manner.	Electronic Records Management
Elektronische Signaturen	Ability to capture and manage electronic signatures in a secure, reliable, and auditable manner.	Elektronische Signaturen

Standard

ISO 13485

Medizinisch

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
Risikomanagement	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
Rückverfolgbarkeit	Ability to trace requirements and their implementation throughout the development process.	Rückverfolgbarkeitsmatrix
Entwurf und Entwicklungsplanung	Ability to plan and manage the design and development process, including requirements management and verification.	SimulationDiagrammingUsecase
Design-Input	Ability to capture and manage requirements and input from stakeholders and other sources.	FAQEmail
Design-Output	Ability to manage design output and ensure that it meets all applicable requirements and specifications.	Testzentrum
Designüberprüfung und -validierung	Ability to verify and validate the design to ensure that it meets all applicable requirements and specifications.	ReviewApproval
Designänderungen	Ability to manage changes to the design throughout the development process, including their impact on other requirements and specifications.	BaselineVersioningImpact Assessment
Dokumentenverwaltung	Ability to manage documents and records associated with the product or service in a controlled and auditable manner.	Smart DocsSmart NoteSmart Reports
Lieferantenmanagement	Ability to manage suppliers and ensure that they meet all applicable requirements and specifications.	Lieferantenmanagement
Ausbildung und Kompetenz	Ability to provide training and ensure the competence of personnel involved in the design, development, and production or service delivery process.	ReviewApproval
Dokumentenverwaltung	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

Allgemein

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
Risikomanagement	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
Risikoanalyse	Ability to analyze and evaluate risks associated with medical devices, including identifying hazards and assessing their severity and probability of occurrence.	Folgenabschätzung
Überwachung nach dem Inverkehrbringen	Ability to monitor and report on the performance and safety of medical devices after they have been released to the market.	Testzentrum
Informationen zur Produktion und Postproduktion	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
Dokumentenverwaltung	Ability to manage documents and records associated with medical devices in a controlled and auditable manner.	Intelligente Dokumente
Rückverfolgbarkeit	Ability to trace requirements and their implementation throughout the development process, including the identification of risks and risk control measures.	Rückverfolgbarkeitsmatrix
Entwurf und Entwicklungsplanung	Ability to plan and manage the design and development process for medical devices, including requirements management and verification.	SimulationDiagrammingUsecase
Design-Input	Ability to capture and manage requirements and input from stakeholders and other sources for medical devices.	FAQEmail
Rückverfolgbarkeitsmerkmale	The tool needs to enable the linking of safety requirements to other requirements and work products to ensure that safety requirements are met.	Verknüpfung von Arbeitselementen
Berichtsfunktionen	The tool needs to provide evidence of compliance with ISO 14971 by generating reports on risk management activities.	Intelligente Berichte

Standard

ISO 17491

Allgemein

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

Relevant feature	Feature description	MR4DevOps feature
Rückverfolgbarkeitsmerkmale	The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.	Rückverfolgbarkeitsmatrix
Anforderungsdokumentation	Ability to document requirements in a clear and concise manner.	Smart DocsCoPilot4DevOps
Entwurf und Entwicklungsplanung	Ability to plan and manage the design and development process for medical devices, including requirements management and verification.	SimulationDiagrammingUsecase
Berichtsfunktionen	The tool needs to provide evidence of compliance by generating reports on risk management activities.	Intelligente Berichte
Veränderungsmanagement	Ability to manage changes to project artifacts, including requirements, design, and code.	Ausgangsbasis

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
Rückverfolgbarkeitsmerkmale	The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.	Rückverfolgbarkeitsmatrix
Anforderungsermittlung	Ability to identify, collect and document requirements from stakeholders.	FAQEmail
Anforderungsanalyse	Ability to analyze requirements for consistency, completeness, feasibility, and testability.	ReviewApproval
Anforderungsdokumentation	Ability to document requirements in a clear and concise manner.	Smart DocsCoPilot4DevOps
Anforderungsmanagement	Ability to manage changes to requirements, including version control and approval workflows.	VersioningApproval
Anforderungsüberprüfung	Ability to verify that requirements have been implemented correctly and meet the specified criteria.	Testzentrum
Veränderungsmanagement	Ability to manage changes to project artifacts, including requirements, design, and code.	BaselineVersioningImpact Assessment
Metriken und Analyse	Ability to collect and analyze metrics related to project progress, quality, and efficiency.	Metriken und Analyse
Zusammenarbeit	Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts.	Smart DocsSimulationSmart ReportsSmart NoteEmailReview
Konfiguration	The tool needs to control and document changes to software requirements, including who made the changes and why.	Folgenabschätzung
Testpläne	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.	Testzentrum

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Add Your Heading Text Here

Learn how MR4DevOps aligns with popular standards

Verwaltung der ISO 26262-Konformität mit modernen Anforderungen

Verwaltung der ASPICE-Konformität mit modernen Anforderungen

21 CFR Teil 11: Häufig gestellte Fragen

Facilitate the Medical Device Design Controls with Modern Requirements

Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Modern Requirements ist nach ISO 9001:2015 zertifiziert.

Standards we cover

Every requirement, mapped to a feature

Ready to make your next audit audit-ready?

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