Arena QMSArena, a PTC Business
|
||||||
Related Products
|
||||||
About
Arena’s product-centric quality management system (QMS) software enables medical device manufacturers to deliver safe and compliant products to market fast. Arena QMS streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena QMS ensures regulatory compliance to various quality standards and regulations, including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans.
|
About
Orthogonal provides specialized development services focused on building and scaling Software as a Medical Device (SaMD) and connected medical device systems, combining modern engineering practices with strict regulatory compliance. Their approach spans the full product lifecycle, including user experience design, human factors integration, requirements definition, risk analysis, Agile software development, and verification and validation to ensure both functionality and safety. It emphasizes the use of Agile methodologies adapted to regulated environments, enabling iterative development, faster feedback cycles, and continuous improvement while maintaining compliance with standards such as FDA, EU MDR, and ISO frameworks. Orthogonal supports the development of mobile, web, and desktop applications, cloud-based systems, AI algorithms, and SDKs that integrate with third-party platforms, allowing medical devices to connect, process data, and deliver insights.
|
|||||
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
Created for medical device manufacturers developing complex products.
|
Audience
Medical device companies, digital health startups, and healthcare technology teams that need to develop compliant, scalable software for connected medical devices and digital therapeutics
|
|||||
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
No information available.
Free Version
Free Trial
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Webinars
Live Online
In Person
|
Training
Documentation
Webinars
Live Online
In Person
|
|||||
Company InformationArena, a PTC Business
Founded: 2000
United States
www.arenasolutions.com/platform/qms/
|
Company InformationOrthogonal
Founded: 2025
United States
www.orthogonal.com
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
|
|||||
|
|
||||||
|
|
||||||
Categories |
Categories |
|||||
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
|
||||||
Integrations
AgentMail
Amazon
Andi
Apollo
Claude Code
ContactOut
Crustdata
Didit
Fundable
Notion
|
Integrations
AgentMail
Amazon
Andi
Apollo
Claude Code
ContactOut
Crustdata
Didit
Fundable
Notion
|
|||||
|
|
|