Accelerating Time-To-Market

The Orcanos Way to Comply with Regulations in Heavily Regulated Industries

Save time, money, and frustration with the only automated proactive management system in the market that uses continuous real-time auditing and is 100% adaptive

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ABOUT US

Understand Orcanos in 120 seconds

our product

the orcanos way

Compliance Management
Compliance Management
Risk Management
Risk Management
Audit-Ready
Audit-Ready
Post-Market
Post-Market
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Compliance Management

1/4

One Place for ALM and QMS

No more ALM and QMS apart. Secured, Robust, and Simple platform for lifecycle compliance management through ALM and QMS that creates one holistic process. Integral updated regulatory databases ensure your products comply with and exceed regulatory requirements.

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Risk Management

2/4

State-Of-The-Art Risk Management

One repository of ALM and QMS enables a state-of-the-art risk assessment. Fully compliant with ISO 14971 and more, to prevent failures and back and forth through the product lifecycle with just one click.

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Audit-Ready

3/4

Audit-Ready

Don't waste time. Orcanos compliance engine is ready for real-time auditing anytime. By using the last reports issued worldwide and an end-to-end traceability test, you would know where to aim to minimize interferences in one click.

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Post Marketing Surveillance

4/4

Post-Market

Be holistic. Orcanos service center integrated into the lifecycle compliance platform makes it realize and perform any actions related to design or quality. It can be fully customized to enable seamless workflows and efficient post-marketing processes.

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need headline

Compliance & Development Should Walk (And Talk) Together

To put high-quality and safe products on the market as quickly as possible, R&D and compliance departments need to work closely together. But you know the routine – the compliance and R&D departments usually interfere. Like there are two languages in one organization.


Orcanos brings a new way to comply by integrating that form into a new language. Now, each party can focus on what does best (and loves). Put happiness aside; this is a new way of working under regulations – more effective, simpler, better – a kind of sprint compliance.

R&D
Quality

Quality
Perspective

Orcanos Quality Perspective

Guarantee safe products with less friction

Ensure meeting the updated standards with continuous monitoring in less time and explanations to the R&D on what to follow. You will be alerted when a change in design occurs, and a new risk assessment or any other action is needed.Make sure you are prepared for any audit at any time.

R&D
Perspective

Orcanos R and D Perspective

Achieve your goals and minimize your time spent on bureaucracy

Be an engineer, not a writer, and make sure the only challenges you face are within your field of expertise.Rather than dealing with bureaucracy, concentrate on development and eliminate back and forth in development. Get Orcanos to produce your paperwork in a compliance-ready format.

Quality
Perspective

Orcanos Quality Perspective

Guarantee Safe Products With Less Friction

Ensure meeting the updated standards with continuous monitoring in less time and explanations to the R&D on what to follow. You will be alerted when a change in design occurs, and a new risk assessment or any other action is needed.Make sure you are prepared for any audit at any time.

R&D
Perspective

Orcanos R and D Perspective

Achieve Your Goals and Minimize Your Time Spent on Bureaucracy

Be an engineer, not a writer, and make sure the only challenges you face are within your field of expertise.Rather than dealing with bureaucracy, concentrate on development and eliminate back and forth in development. Get Orcanos to produce your paperwork in a compliance-ready format.

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testimonial

What our clients say about us

Very good value for money, very helpful with preparations for audits

I truly have nothing but the highest praise and appreciation for all that you did for us. Saving me on the video montage projection was huge, and even more important the amazing pictures.

Shirley Barnes
New York Times

Very good value for money, very helpful with preparations for audits

I truly have nothing but the highest praise and appreciation for all that you did for us. Saving me on the video montage projection was huge, and even more important the amazing pictures.

Shirley Barnes
New York Times

Very good value for money, very helpful with preparations for audits

I truly have nothing but the highest praise and appreciation for all that you did for us. Saving me on the video montage projection was huge, and even more important the amazing pictures.

Shirley Barnes
New York Times

Very good value for money, very helpful with preparations for audits

I truly have nothing but the highest praise and appreciation for all that you did for us. Saving me on the video montage projection was huge, and even more important the amazing pictures.

Shirley Barnes
New York Times

reasons

WHY CHOOSE ORCANOS

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

EASY CUSTOMIZATION

Powerful customization tools to customize your quality forms, E-sign processes, status flows, mandatory rules and permissions

SEE
MORE
FEATURES

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DASHBOARDS AND ANALYTICS

Better tracking & control with custom reports and charts builder, to track projects progress and quality procedures status.

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

YOUR VIRTUAL AUDITOR

Use Orcanos Compliance Engine to get a real-time audit of your projects, anywhere, anytime!