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The Leading MedTech eQMS
Get up and running quickly with our best practice templates
and adaptive compliance, available at any scale.
MedTech Suits
#1 Trusted QMS Software
A comprehensive cloud-based medical device Quality Management System (QMS) ensuring your products exceed regulatory compliance standards.
A Complete ALM System
Improve delivery time by utilizing software that integrates Application Lifecycle Management (ALM) and regulated Design Control.
Bridge the Gap: Streamlining Communication Between QA and R&D
Are you struggling with a lack of communication flow between your teams? Elevate collaboration, enhance efficiency, and drive innovation with Orcanos.
Unifying QMS with ALM for better MedTech Compliance
Orcanos platform integrates Application Lifecycle Management and Quality Management System processes for efficient compliance management. This unique approach saves costs, reduces frustration, and shortens the time to market. It benefits both development and quality teams while meeting regulatory standards.
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Document Control: Efficient Signoffs & Revision Tracking
Automate your compliance processes and reduce the bottlenecks on document routing and sign-off. Fire training tasks and use Orcanos Change Control to release new revisions.
Adaptive Compliance
Replace paper-based QMS with Orcanos quality management software electronic forms, and achieve higher productivity and efficiency.
Risk Management (ISO 14971)
Incorporating risk management into your development and Quality Management System procedures is essential if you want to attain full traceability and save up to 30% on manual management costs.
What our clients say about us
"We obtained CE certification and FDA clearance with Orcanos."
We were impressed by Orcanos' attention and expertise in the medical device industry, and we felt it was the right choice for us. Having obtained both CE certification and FDA clearance with Orcanos, we are confident that we made the right choice for ZygoFix.
"Orcanos completely streamlines the Change Order and Document Control process for us."
Non-Conformance, CAPA, and Audit workspaces are next in line, keeping everything organized so we never miss a step. Orcanos's platform is tailored for medical device companies, providing all the tools we need.
What makes Orcanos stand out?
ALM and QMS
Integrate Design Control (ALM) with Quality Management System and regulation to establish a centralized repository.
Document Generator
Effortlessly generate submission-ready documents (in Word or Excel) that conform to your company's templates.
Integrated Risk Management
Integrating risk management into the development process and quality events helps prevent potential hazards and failures while following ISO 14971 guidelines.
21 CFR Part 11 Compliance
Orcanos supports electronic records and electronic signatures in compliance with 21 CFR Part 11/Annex 11.
Dashboards And Analytics
Keep track of projects and the status of quality procedures with detailed reports and charts through our customized dashboards.
Easy Customization
Our platform offers powerful customization tools to tailor your quality forms, e-sign processes, status flows, mandatory rules, and permissions to your specific needs and your company's Standard Operating Procedures.
Take your regulatory compliance to the next level with Orcanos. Book a demo today and experience the power of our integrated solutions firsthand!
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