Compliance Management

Streamline Your Design Control, Quality Management, And Regulation Compliance In Single Integrated System

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ALM/ Design Control

Full Integrated

Quality Management

Easy Customization

Nonconformance

Training

Deviations Management

Regulation Compliance

Fully Automated

21 CFR Part 11

FDA 21 CFR Part 820

ISO 14971

ISO 13485:2016

IEC 62304

Our Clients Testimonials

“ORCANOS Medical provided a platform to easily deal with complexities entailed in capturing and managing of Product Requirements (System, Software, Hardware, Mechanical, etc) , Risks Management and Traceability in a highly regulated environment…”

Igor Stankovski

Technical Program Manager, Fio

“Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…”

Eli Zehavi

Co-Founder, Mazor Robotics

Oren Tamari

CEO, Upnride

“…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…”

Key Features

ALM+QMS

Combine Design Control (ALM) with quality management system and regulation in a central repository

Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971

21 CFR Part 11 Compliance

Define electronic signature process for a complete documents approval lifecycle

Easy Customization

Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions

Dashboards And Analytics

Better tracking and control with custom reports and charts builder, to track projects progress and quality procedures status, such as requirements traceability, test run results, risk assessment, CAPA and more

End To End Traceability

Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability

Realtime Alerts

Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week