Clock Icon - Technology Webflow Template
min read

Digitizing Compliance: Streamlining the Entire Lifecycle from R&D to Production and Quality Management

Since 2020 - Supporting Design Control, QMS, Manufacturing, eDHR automation, and BOM

Cardiac Health Monitoring
Caesarea, Isreal

Company Overview: Advancing Cardiac Health Monitoring

Cardiacsense at a Glance

Founded in 2012, Cardiacsense has made significant strides in health technology by developing a sophisticated watch for continuous monitoring of heart arrhythmias and blood pressure. This device, supported by a robust IP portfolio in optics, mechanics, and signal processing, is in the advanced stages of FDA and CE certification, marking a breakthrough in long-term health monitoring.

“Orcanos designed the solution very well in that it doesn’t require a lot of direction" Asaf Omer - QA&RA Manager

The Transformation Challenge: Scaling Up with Digital Solutions

Evolving Needs for Modernization

As Cardiacsense grew and faced evolving regulatory landscapes, the necessity to modernize their management of quality documents and production records became evident. The paper-based systems were no longer sustainable for the company's expanding operations and compliance requirements.

From Paper-Based Systems to Digital Efficiency

Before Digitalization: The Pain Points

Cardiacsense's operations were bogged down by inefficient paper-based processes, with physical cabinets filled with documents, leading to uncontrolled documents and poor collaboration. Regulatory Compliance Manager Asaf Omer shared, "All our procedures and production records were printed and written out by hand. Procedures were typed, but they had to be printed as hard copies." This method was cumbersome and prone to errors, making document management and collaboration challenging.

Choosing Orcanos for a Digital Overhaul

To address these challenges, Cardiacsense turned to Orcanos, aiming to digitize their quality and production records. This decision was propelled by the need for better document control, efficient collaboration, and compliance with updated regulatory standards.

Implementing Quality and Production Solutions in Parallel

A Dual Approach for Immediate Impact

Recognizing the urgency, Cardiacsense and Orcanos opted to implement electronic quality management system (eQMS) solutions and electronic engineering BOM/DMR/ECO records in parallel. This strategic move was aimed at minimizing disruption while maximizing efficiency across operations. VP of Operation, Yaniv Inbar, noted the seamless transition, "It’s scary and a little bit daunting to think we’re moving our entire QMS to the electronic world. But the way it was implemented, methodically, worked for us."

The Digital Transformation: Outcomes and Insights

From Paper to Digital: Streamlining Operations

The shift to Orcanos's digital solutions revolutionized Cardiacsense's operations, making information more accessible and improving data integrity. The transition not only enhanced collaboration but also significantly reduced the time spent on managing documents. Asaf Omer emphasized the benefits, "Orcanos will improve our accessibility of information and visibility of our finished product... I see record retrieval, the ease of access to information, as a big value for us."

ERP Integration and BOM Management

A key component of Cardiacsense's transformation was integrating Orcanos with its ERP software, NetSuite. This integration facilitated the direct pull of materials information into the electronic production record, eliminating data integrity issues and improving overall data analysis capabilities. The streamlined BOM release process, as described by Yaniv Inbar, "The BOM release process before using Orcanos took too long... With the advance ERP in the cloud and Orcanos also in the cloud, I can potentially integrate them both and release products from anywhere in the world."

The Results:  

  • Enhanced Efficiency and Regulatory Compliance.
  • Cardiacsense's digital transformation with Orcanos has brought about significant operational efficiencies, improved regulatory compliance, and fostered a culture of innovation. The ability to quickly release products and manage changes has been a game-changer for the company.
  • A Foundation for Sustained Innovation.

Future Outlook

Looking ahead, Cardiacsense is well-positioned to continue its trajectory of growth and innovation. The digital foundation established with Orcanos supports the company's long-term strategy to lead in cardiac health technology.

Trusted by