Orcanos new Calibration Services + IceCure FDA approval + MEDICA 2024 & Expanding partnership with R.S NESS

Welcome to the October edition of Orcanos Software Monthly Digest!

As we approach the end of the year, we are happy to share our reflections on success with true stories from our customers. With the rising economic challenges globally, we found our partners to be a true strong backbone that shares the same values and objectives to help the regulated industry on its journey. We're excited to share the latest news, content, and updates with you each and every month. Plus, we'll be sharing much more, so stay tuned!

Watch our launch video

MEDICA 2024 Nov. 11-14, 2024

by Rami Azulay (Orcanos CMO)

Where healthcare is going, we go.

This year Orcanos is visiting MEDICA event @ Dusseldorf, Germany. Like every year, we will be meeting our customers, enjoying the professional audience we are about to meet, and most of all, presenting our technology at the startup pavilion, sharing our innovation around the eQMS AI. This year, we are extremely interested in meeting with manufacturers who reached critical mass in their production line, where QC over manual DHR is holding their scale-up.?

Scan the code, and let's share with you our success with other customers.?

IceCure Elza’s journey to FDA clearance

by Yoni Alon (Orcanos PMO)

IceCure Medical started working with Orcanos in 2019. IceCure Medical selected starting with both design control (product lifecycle management) and QMS managing DHF/DMR to support IceCure's products portfolio: a new line of products named XSense aiming for MDR/FDA submissions and sustain for Prosense family products.

Naum Muchnik, VP R&D at IceCure, said, “We determined that there had to be a better way to document and distribute requirements to stakeholders. We found the optimal solution in Orcanos. We knew about Orcanos many years before we started using it for IceCure. The price and the value were a perfect fit to what we were looking for.” he said. “The attention we needed from Orcanos as a startup gave us the backwind we needed to jump into this digital world, we know we have made the right choice for IceCure and looking forward to keeping growing with them”

Customer testimonials

by Zohar Peretz (Orcanos CEO)

Lidar Mazor

Director, Head of Projects

"Orcanos has streamlined our quality management processes"

As a project manager in the medical device industry, Orcanos has streamlined our quality management processes, ensuring compliance and efficiency. Its intuitive platform allows us to seamlessly manage projects, reduce risks, and accelerate product development. Zohar Peretz says, “Our customer loyalty goes for years forward even after moving between jobs. This is how proud we are of them. We keep learning from them and building with them our future roadmap to give cutting-edge solutions to market needs”

Akanksha Choudhary

Regulatory Affairs Specialist, Summus Lasers

"Orcanos completely streamlines the Change Order (ECO) and Document Control process"

As regulatory affairs specialists at Summus Lasers, we used Orcanos to completely streamline the Change Order and Document Control process for us. The Nonconformance, CAPA, and Audit workspaces are next on the go, helping us to organize them in a way so you never miss a step with what needs to be documented. The platform Orcanos has is built for medical device companies and has everything we need.

Orcanos Certified Suppliers Services

by Zohar Peretz (Orcanos CEO)

Elevate Your Quality Management with Orcanos eQMS and Scalar Calibration Services.

Scalar Joined the Orcanos Service Partner Program

With this new partnership Orcanos and Scalar, we bring together the best practice of electronic quality management (eQMS) and calibration (ISO 13485, Clause 7.6 Control of monitoring and measuring equipment) services to provide a comprehensive solution for your business needs. In partnership with Scalar Laboratories, we offer unparalleled value and expertise, ensuring your operations run smoothly and efficiently.

The Power of Orcanos eQMS

Orcanos eQMS (electronic Quality Management System) is designed to streamline your quality management processes, specifically your calibration plan and execution, ensuring compliance, reducing risk, and enhancing productivity. Our software solution provides:

• Integrated Quality Management: Centralize your calibration tools documentation in a single platform.
• Regulatory Compliance: Ensure adherence to industry standards and regulations with ease (Part 11).
• Asset Management: Identify, plan, maintain, assess, and execute maintenance tasks effectively.
• Document Control: Maintain and control all your calibration certifications in a secure environment.
• Calibration Management: Simplify communication with calibration service providers using proactive messaging tools.

Scalar Calibration Services: Precision and Reliability

Scalar Laboratories is a leading provider of calibration services, accredited to ISO/IEC 17025:2017 standards. Our joint services include:

• Accessibility: Technicians are available nationwide with a mobile laboratory for on-site calibration.
• Immediate Availability: 24/7 SOS services are available to address urgent needs.
• High Efficiency: Skilled teams delivering fast and accurate results.
• Instant Certification: Immediate issuance of certificates, including requirements, results, and calibration uncertainty.

Why do we Certify our Partners?

By working with Orcanos or Scalar, you gain access to a robust, integrated solution that enhances your quality management and calibration processes. Our partnership offers:

• Comprehensive Support: From initial setup to ongoing maintenance and support.
• Cutting-Edge Technology: Leveraging the latest advancements in eQMS and calibration.
• Expertise and Experience: Decades of combined experience in quality management and calibration services.
• Peace of Mind: Knowing your operations are compliant, efficient, and reliable.

For further information or to join our program, please reach out to:

Orcanos Business Development Team Contact: Rami Azulay , CMO Email: [email protected] Phone: +972.54.444.0255

Scalar Laboratories Contact: Udi Birkhahn , Customer Manager Email: [email protected]? Phone: +972.52.838.3828

Together, we ensure quality and precision in every step of your journey.

Orcanos Compliment Medical Device customers with GAP analysis conducted by R.S-NESS

by Rami Azulay (Orcanos CMO)

Orcanos and R.S NESS Group Join Forces to Elevate Medical Device Compliance and Audit Readiness.?

R.S NESS? Group and Orcanos offer a complimentary quality GAP analysis service Program.

Today, we release an important update regarding the joint partnership between Orcanos and R.S NESS Group - Solutions For Life Science Companies Group service collaboration.

[Tel Aviv, Israel, Oct 2024] – Orcanos, a leading provider of quality management and compliance solutions, is excited to announce a strategic partnership with R.S NESS Group, an industry leader in regulatory services for medical device developers and manufacturers. Together, this collaboration aims to empower organizations to navigate the increasingly complex regulatory landscape, ensuring audit readiness and compliance with international standards.

In today’s rapidly evolving medical device industry, developers and manufacturers face growing challenges in meeting stringent regulatory requirements. R.S NESS Group understands these challenges and is committed to helping businesses overcome regulatory barriers while maintaining audit preparedness.

Through this partnership, Orcanos and R.S NESS offer an exclusive GAP Analysis Service that addresses three critical areas for medical device companies:

1. Audit Readiness - R.S NESS specialized Team and Orcanos support companies in ensuring they are fully prepared for internal and external audits, including compliance with both local and international regulations.
2. Standard Compliance - By aligning the company’s quality management systems (QMS) and processes with industry standards such as ISO 13485 and FDA 21 CFR 820, R.S.NESS ensures that businesses are ready to meet global compliance benchmarks.
3. Advanced Tools Evaluation - The partnership leverages Orcanos' cutting-edge quality management and data management systems (DMS), providing streamlined operations and regulatory compliance. RS-NESS evaluates and implements the most advanced tools to support long-term efficiency and compliance in even the most challenging environments.

"We at R.S NESS Group understand the growing challenges medical device developers and manufacturers face in complying with regulatory standards and ensuring audit readiness," said Maroun Yacoub BizDev, R.S NESS Group. "Our comprehensive GAP analysis service, in collaboration with Orcanos , is designed to address the critical pain points of regulatory compliance, audit preparedness, and advanced technology implementation."

For more information on how this partnership can benefit your organization, visit R.S NESS Group - Solutions For Life Science Companies or Orcanos .