Application
Lifecycle
Management

Improve your delivery time by utilizing software that integrates Application Lifecycle Management (ALM) and regulated Design Control.

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ALM software

Requirements Management Tool

With Orcanos ALM Requirements tool, you can easily plan, approve, trace, and validate industry requirements, manage audits, and ensure regulatory compliance.

Schema of the ALM process: Plan > Approve > Trace > Validate
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Integrated
Risk Management

Integrating Risk Management into your development process can prevent failure and save up to 30% of resources. Generate a Risk Management file that is fully compliant with ISO 14971 standards with one click.

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Test Management

Streamline verification and validation processes in a single ALM platform. The Test Management tool tracks and analyzes results in digital formats, including Word, PDF, and Excel.

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Defect Tracking

The Defect Tracking system enables project participants to submit, query, and export product issues throughout the development lifecycle.

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Customer Service

Achieve full compliance with MDR for post-market and market surveillance. Easy to use, configured, and fully integrated with quality management and design control.

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Traceability Management

Simple and powerful traceability matrix management between any ALM or QMS artifact.

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With Orcanos, you can rest assured that no documents will be overlooked, and no compliance or due dates will be missed.

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Orcanos' Benefits

Single Repository for R&D Quality And Regulations

Orcanos ALM system provides a single data repository that combines research and development, quality management and compliance regulations. This means that companies can manage all required elements – testing, risk management, CAPA, and change management, all in one place.

End-To-End Traceability

System includes a simple and powerful tool – Traceability Matrix Management – that allows interaction between any ALM or QMS artifact during the process. This includes but is not limited to project requirements, test cases, FMEA risk items, CAPA and customer complaints.

DHF Document Generation

The product database can be displayed using various customizable templates that can include tables, visual images, and dynamic data sets embedded within them.

Impact Analysis

Orcanos will issue notifications to end users when any change impact is detected via our filters and alerts mechanism.

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The system is powerful and comprehensive, providing support for medical device companies. Despite its complexity, the solution is simple to apply, connect, and operate.

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FAQ

Questions teams ask before choosing Orcanos

Everything you need to know about our platform, compliance coverage, and getting started.

What is Design Control (ALM) for medical devices?

Design Control (ALM) for medical devices means managing requirements, risk, design, testing, and defects as one connected record instead of separate documents. Orcanos combines Design Control (ALM) with a regulated quality system, so every artifact stays traceable and audit-ready from concept through release.

How does Orcanos Design Control (ALM) support requirements traceability?

Orcanos builds traceability automatically through its Traceability Matrix. Every requirement links to its design outputs, test cases, FMEA risk items, defects, CAPAs, and complaints, so you can prove coverage in seconds and see instantly which requirements have no verification behind them.

Does Design Control (ALM) support ISO 14971 risk management processes?

Yes. Orcanos includes integrated FMEA risk management aligned with ISO 14971, and risk items link directly to requirements, design controls, and test evidence. You can generate a complete Risk Management File in one click rather than rebuilding it manually before each audit.

What is requirements management software for medical devices?

Requirements management software is a controlled system for capturing user needs, design inputs, and design outputs, then approving and tracing them. Orcanos lets teams plan, approve, trace, and validate requirements in one place, replacing spreadsheets that break traceability as a project grows.

How does Orcanos handle medical device software testing?

Orcanos Test Management covers verification and validation in the same platform as requirements and risk. Teams build test plans, execute runs, log defects directly from failed steps, and export results to Word, PDF, or Excel as objective evidence for design reviews and audits.

Is Orcanos Design Control (ALM) used for software as a medical device?

Yes. SaMD and software-enabled device teams use Orcanos to trace requirements through to code-level testing and defects while maintaining the software lifecycle records SaMD teams are expected to produce. The Orcanos REST API connects automated test frameworks, so automated results feed the same traceability chain as manual testing.

How do design controls connect risk and requirements?

Design controls create the formal chain: user needs become design inputs, inputs become outputs, and each is verified and validated. Risk controls attach to that chain. Because Orcanos holds requirements, risk, and test evidence in one repository, changing any of them flags the linked items automatically.

What reports can we export for regulatory submissions?

Orcanos generates submission-ready documents from live project data using your own company templates: Design History File, traceability matrices, risk management files, and test reports, exported to Word, PDF, or Excel. Nothing has to be copy-pasted between systems before a 510(k) or technical file review.

Can Design Control (ALM) software integrate with engineering dev tools?

Yes. Orcanos offers REST and SOAP APIs plus a Zapier connector, linking it to Jira, Microsoft Visual Studio, Teams, Salesforce, and automated test frameworks. Development work stays in the tools your engineers already use, while the compliance record updates automatically inside Orcanos, so engineering isn't maintaining two versions of the same decision.

Is Orcanos Design Control (ALM) the same as a requirements management tool like Jama?

No. Requirements tools like Jama trace requirements and tests well, but they have no native QMS, so teams still run a separate eQMS and manually bridge data between the two systems. Orcanos keeps requirements, risk, design controls, and quality records in one system, so a design change and its compliance impact are visible in the same place instead of reconciled by hand afterward.