Compliance Management

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

30 DAYS FREE TRIAL

SCHEDULE DEMO

Medical Device Compliance

ALM/ DESIGN CONTROL

An integrated ALM system that includes:

Requirements Management

Test Management

Defect Tracking

FMEA Risk Management

QUALITY MANAGEMENT

Fully custoimizable QMS System

Document Control

CAPA

Complaints

ECO

Non Conformance

Audit

And much more

REGULATIONS

Assure your Regulations Compliance

21 CFR Part 11

FDA 21 CFR Part 820

ISO 14971

ISO 13485:2016

IEC 62304

GMP Compliance

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Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents.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

Products

ALM
Quality Management System
Service Center
Try Orcanos
Request Demo

Company

About Us
Leadership
Clients
Partners

Resources

Blog
Workshops
Security Center
Sitemap

Support

Online Help
Tutorials
Service Center

Contact

8Beit Oved Street
Tel Aviv, Israel
+972-3-5372561
info@orcanos.com