Design Control

Improve your delivery time and gain confidence in every stage of development with a compliant, transparent, and audit-ready design control process.

Streamlined Design Control for Medical Device Compliance

Design control is more than a regulatory requirement—it’s the foundation of safe, effective product development. Orcanos unifies design inputs, risk management, verification, and validation in one connected ALM + QMS platform. Maintain full traceability, ensure compliance with ISO 13485 and 21 CFR Part 11, and accelerate time to market—without compromising quality or safety.

Secured, Robust and Simple 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.

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.

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.

Defect Tracking

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

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.

Traceability Management

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

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

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.

Just Start Working ...

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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