+
+

Related Products

  • isoTracker Quality Management
    19 Ratings
    Visit Website
  • Intelex
    166 Ratings
    Visit Website
  • HSI Donesafe
    172 Ratings
    Visit Website
  • Interfacing Integrated Management System (IMS)
    66 Ratings
    Visit Website
  • SBS Quality Management Software
    7 Ratings
    Visit Website
  • AlisQI
    96 Ratings
    Visit Website
  • Certainty Software
    87 Ratings
    Visit Website
  • Qualio
    884 Ratings
    Visit Website
  • Predict360
    18 Ratings
    Visit Website
  • Process Street
    1,119 Ratings
    Visit Website

About

Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.

About

Eliminate manual, repetitive tasks so you can focus on delivering safer, more effective products – faster. IQVIA’s SmartSolve Postmarket Surveillance is your complete, SaaS approach for postmarket surveillance (PMS) and provides best practices for centrally managing all post market surveillance activities. Fusion is a SmartSolve and RIM Smart user event that provides an in-depth education into timely and relevant quality and regulatory topics with actionable insights and practical tools that can be applied within any Life Sciences organization. Fusion started as a live SmartSolve user conference and has evolved over the past couple of years to include virtual and live events for both SmartSolve and RIM Smart users. Simplify, automate and integrate your compliance response times, accuracy, predictive planning and efficiency with IQVIA SmartSolve™ Regulatory Connector. Connected Intelligence is our innovative, interconnected approach that helps to drive operational efficiencies.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability

Audience

Companies searching for a solution to manage and improve their surveillance operations

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

$542 one-time payment
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Company Information

IQVIA
Founded: 1982
United States
www.iqvia.com/solutions/integrated-global-compliance/quality-compliance/smartsolve-eqms

Alternatives

Modern Requirements4DevOps

Modern Requirements4DevOps

Modern Requirements

Alternatives

Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
aligned elements

aligned elements

Aligned AG
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Categories

Categories

Application Lifecycle Management Features

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management Features

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Document Management Features

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Training Features

Academic / Education
Asynchronous Learning
Blended Learning
Built-In Course Authoring
Built-in LMS
Certification Management
Corporate / Business
eCommerce
Learner Portal
Mobile Learning
Simulation
Synchronous Learning
Training Companies

Integrations

Indent
Jira
Microsoft 365
Salesforce

Integrations

Indent
Jira
Microsoft 365
Salesforce
Claim Orcanos and update features and information
Claim Orcanos and update features and information
Claim SmartSolve eQMS and update features and information
Claim SmartSolve eQMS and update features and information