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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.

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MedTech Suits

#1 Trusted QMS Software

A comprehensive cloud-based quality management system ensuring your products exceed regulatory compliance standards.

Open QMS

A Complete ALM System

Improve delivery time by utilizing software that integrates Application Lifecycle Management (ALM) and regulated Design Control.

Open ALM

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.
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Three overlapping circles of Regulations, ALM and QMS with Risks in the middle.

Unifying QMS with ALM for better MedTech Compliance

Orcanos platform integrates ALM and QMS 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.

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Picture of a hand with a marker writing on a board

Adaptive Compliance

Replace paper-based QMS with Orcanos customizable electronic forms, and achieve higher productivity and efficiency.

Powerful customization tools and simple templates

No coding is required; simply drag and drop

Build custom workflows in just a few clicks

Setup traceability between different artifacts

Supporting a wide variety of field types

Complete access control

Risk Management (ISO 14971)

Incorporating risk management into your development and QMS 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.

Akanksha Choudhary

Regulatory Affairs Specialist at Summus Laser

"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!