Requirements Management Tool

Reduce the cost spent on manual traceability

gohnson & gohnson
Mazor Robotics
Biosense Webster
Fio Corporation

Orcanos requirements management tool simplifies tracking of your requirements. Flexible enough to serve SMBs and powerful enough for enterprises.

  • Single repository for all types of requirements management
  • Simple Import/Export from Word
  • Collaboration
  • Medical Device compliance, with 21 CFR Part 11 support
  • End-to-end traceability with impact analysis
  • Real-time dashboards, alerts, and notifications

The Design Input Requirement Categories

Using the User Requirement Specification (URS), one of 58 types of requirements can easily generate several input requirements documents. Input Requirements some often fall into three categories namely;

  • The Functional Requirements (FRS): This requirement specifies the capabilities of the devices, its operations as well as its input and output characteristics.
  • Performance Requirement (PR): It covers the device behavior during use, and some of the behaviors can include; precision, ranges of quantitation accuracy, operational environmental ranges, and other performances.
  • Interface Requirement (IR): All interface requirements should be specified. Interface requirements can be either external or internal. However, all specifics relating to the interface should be listed.  External interfaces can be in the form of patient/product interface, external communication interface, and operation/product interface. Meanwhile, the internal interface can be software/hardware and communication interface. Each interface requires a review to ensure that the system works well together.

The documentation for each requirement often depends on the product and the organization. Although, almost all organization have functional requirement documentation or documentation that directly addresses design input requirements (DIR). Sometimes there are separate documents to capture specific requirements of the document such as a Mechanical Requirement Specification (MRS). Another example is the Electrical Requirement Specification (ERS) that are created within the sections or either the DIR or FRS documentation, Orcanos ALM system support over 58 different types of requirements and can be expended to more as needed.

Other requirements that deserve consideration are safety and regulatory requirement. We mustn’t forget the requirements for applicable risk management inputs.

FMEA Risk Management

Requirements Management Tool for Medical Devices

Orcanos medical requirements management tool is a perfect fit for manufacturers of medical devices and will provide you with

  • Central requirements management repository
  • Electronic signature, 21 CFR Part 11 compliant
  • Requirements tractability matrix
  • Generate requirements documents
  • Requirements traceability to risks, thus satisfying ISO 14971
  • Supports multiple types of requirements
  • Requirements verification using Orcanos test management tool
  • Full audit trail and history log
  • Baseline management

End-to-End Traceability

Orcanos requirements traceability tool helps companies track coverage and traceability between any ALM artifact, such as system requirements, hardware and software requirements, test cases (see: test management), risk, and more.

Using the Orcanos traceability matrix you can integrate R&D with quality management modules, such as FMEA for risk management, CAPA and customer complaints, thus satisfying medical device regulations.


Learn more

Requirements Management - traceability matrix

Online Document for better collaboration

Orcanos Online Document enables documents collaboration. Multiple users can access the same document together, while preserving document integrity and data security.

MSWord Document Generator

Orcanos DocGen is used to generate documents from Orcanos electronic records repository. Supporting embedded reports, and customized templates.

  • Embedded reports
  • Custom Templates

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Requirements management Tree

Hierarchic Requirements Management View

Create hierarchical documents of requirements with a Word-like online Editor.

Easily build your documents structures according to your organizational needs, use predefined templates and easily share documents between users

This is the moment when you
choose your way to succes.

Requirements Management

Features List


  • Add/edit/del/query requirements in a single repository

  • Manage entire lifecycle

  • prioritization

  • Capture source of requirements

  • Define a stakeholder for each requirement

  • Define and capture different types of requirements with full customization

  • Customize requirement attributes and layout

  • Manage backlog

  • Data reuse

  • Copy & Share

  • Automatically create unique ID for each requirement

  • Classify requirements by attributes

  • Mass update of attributes

  • Create custom lists

  • Various exporting capabilities

  • Restrict two people from working simoultaneously

  • Drag-and-drop ability to move requirements within the document

  • External API available for automation

Requirements Editing

  • Embedded HTML editor

  • Automatically check requirements for spelling errors

Requirements Traceability

  • Trace requirements at all levels

  • Support upstream and downstream Traceability

  • Full traceability matrix, summary and detailed view

  • Impact analysis

  • Cross-Project Linking capability.

  • Use baselines to track chnages

  • Identify missing links

  • Navigate upstream and downstream

  • Define link types

  • Generate traceability reports

Generate Word Documents

  • Export requirements to Word/PDF/HTML/CSV/Excel/XML with one click

  • Customize templates and styles

  • Preview of requirements document generation

Requirements Validation and Verification

  • Requirements verification by test cases

  • Baseline Management

  • Create a regression test suite based on the requirements

  • Create a system test suite based on the requirements

Search, Custom Views and Personal Dashbaords

  • Strong filtering capabilities and dashboards

  • Inconsistency alerts and notifications

  • Filtering based on attributes and associated data types

  • Audit Design Basis

  • Strong search capabilities

  • Sort custom views

  • Save private/public custom views

  • Report on who is working on what requirements

  • Filter for a list of new/changed requirements and review the changes

  • Customize and view dashboard reports

Electronic Signature, Review And Audit

  • Track requirements approval/signoff

  • Request requirements approval/signoff via email

  • Report on whether a set of requirements have been reviewed (looked at)

  • Electronic signature according to 21 CFR part 11

Requirements Baseline And Version Management

Data Sharing And Permissions

  • Share information using emails, and instant messaging

  • Control the permissions based on the user role

Discussions And Instant Messaging

Manage discussions – capture the discussions related to the requirements within the System

History Log And Audit Trail

  • 21 CFR part 11 compliance

  • Full history log for audit trail

  • Track conversations about requirements, attach conversations to requirement objects

  • Automatically maintain audit trail for requirement changes (user, time/date, annotation of change, and change detail)

  • Notify affected project participants by e-mail about requirement changes

Requirements Import And Export

  • Import data from Excel, XML

  • Export a subset of requirements based on a filter view applied



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