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Aligned Elements

by Aligned AG

Aligned Elements Product Summary

Aligned Elements Screens & Videos

From our Sponsors

Aligned Elements Product Details

Aligned Elements Medical Device ALM delivers world-class Design Control Management to accelerate your Technical File / Design History File completion. Built for Medical Device development from the ground up, Aligned Elements supports industry standards regulations such as MDR/IVDR, ISO 13485, ISO 14971 and FDA QSR 820 out-of-the-box. Aligned Elements provides seamless design control traceability, integrates risk assessment, as well as verification, and validation activities, essential for completing the TD/DHF. The result is a complete, correct and consistent technical documentation, enabling rapid approvals and an accelerated market access.

Aligned AG

Founded in 2006

Located in Z├╝rich, Switzerland

https://www.aligned.ch/

Aligned Elements Screens & Videos

From our Sponsors

Aligned Elements Pricing

Aligned Elements pricing starts at $1300 per user per year.

Aligned Elements offers a free trial. Get your free trial: https://www.aligned.ch/free-trial

Aligned Elements Support

Deployment

Installed - Mac
Installed - Windows
Installed - Linux/Unix
Web-Based, Cloud, SaaS
iPhone / iPad
Android

Training

In Person
Live Online
Webinars
Documentation

Support

Business Hours
Online
24/7 via Live Rep
24/7 via Online Ticket

Aligned Elements Features

Requirements Management
  • Requirements Catalog
  • Epics
  • Feature
  • User Stories
  • Use Cases
  • Defect Management
  • Requirements Traceability
  • Requirements Prioritization
  • Requirements Reuse
  • Requirements Verification & Validation
  • Custom Requirement Attributes
  • Workflow and Task Management
  • Multi-User Collaboration
Administration & Security
  • Role Management (Permissions Management)
  • Administrator Level & User Level Management
  • Single Sign On (SSO) and IP restrictions
  • Multi-factor Authentication (MFA)
  • User Audit Logging
  • User License Management
Requirements Specification
  • Business Requirements Document (BRD)
  • Functional Requirements Document (FRD)
  • Software Requirements Document (SRD)
  • Product Requirements Document (PRD)
  • Use Case Specifications
  • Custom Reports & Templates
  • Export (Word, Excel, PDF, HTML, etc.)
  • Test Case Specifications
Application Lifecycle Management (ALM)
  • Requirements Management
  • Workflow Automation
  • Test Case Management
  • Test Script Management
  • Document Management
Product Lifecycle Management (PLM)
  • Requirements Management
  • Workflow Automation
  • Test Case Management
  • Test Script Management
  • Document Management
  • Change Management
  • Regulatory & Compliance
  • Product Design

Aligned Elements Product Details

Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry.

We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.

At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.

We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.

2024-06-20 Aligned Elements Aligned Elements

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