Orcanos QMS: The Future of Medical Device Quality Management
Compliance, Risk Management & Design Control—All in One Platform
Developing a medical device is complex. Compliance requirements, risk management, and design control must align seamlessly to avoid delays, reduce costs, and ensure patient safety. Orcanos’ cloud-based Quality Management System (QMS) simplifies the entire process—helping you stay compliant while accelerating innovation.
Accelerate your process to achieve
ISO 13485 compliance
Orcanos QMS software provides a centralized platform to control all quality processes. This eliminates the need for a paper-based quality system and enables organizations to comply with strict FDA regulations and established ISO quality standards.
Document Control
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.
Risk Management
ISO 14971
Integrating risk management into your QMS processes streamlines compliance with ISO 14971 and reduces risk throughout the device lifecycle.
Change Management (ECO)
Automate change management workflow and release a set of documents in a single batch.
Complaints Handling
Full Complaints Handling system, configure your workflow, leading you from investigation to resolution.
CAPA Management
Achieve compliance and enhance your quality control processes with Orcanos CAPA management.
Audit Management
Get better prepared for your next audit or inspection.
Nonconformance
Orcanos' nonconformance management simplifies the recording and tracking of non-conformance issues, from identification to resolution.
Training Management
Streamline Your Employee Training with Orcanos' Training Management Software.
Supplier Qualification
Consolidate all relevant documents, specifications, supplier schedules, scorecards, quality events, and risk assessments into a single, streamlined QMS.
Get ready for your next audit today!
Schedule a demo now to experience the power of our integrated solution.
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.
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