Streamlined Compliance Collaboration
Circle Cardiovascular: Revolutionizing Heart Health
Founded in 2007, Circle Cardiovascular Imaging has established itself as a global leader in cardiovascular image-processing software. Headquartered in Calgary, Canada, the company has built a global sales force and a robust network of distributors worldwide, ensuring its innovative solutions reach healthcare professionals around the globe.
From its inception, Circle Cardiovascular has been at the forefront of revolutionizing cardiac care through advanced imaging technology. The company’s innovative software solutions have garnered acclaim for their accuracy and automation, enabling clinicians to improve the efficiency and precision of cardiovascular image reading and reporting.
Kyle Mayr, Director of Regulatory Affairs and Quality Management Systems at Circle Cardiovascular Imaging, oversees the maintenance of crucial certifications like ISO 13485 and the marketing of their devices in various countries. "My role involves ensuring our products meet regulatory standards across different regions, which can be quite complex given the varying regulations," Kyle explains. The company’s primary products, mostly classified as Class II medical devices, require meticulous regulatory compliance to enter new markets.
Exponential Growth Made Possible: Working With Arazy Group To Increase Circle Cardio’s Global Footprint
A critical factor in Circle Cardiovascular Imaging’s success has been its strategic approach to global expansion. With a strong global direct sales presence, the company ensures that its innovative solutions reach a global audience, making a significant impact on cardiac care internationally. This global presence has allowed Circle Cardiovascular Imaging to stay at the forefront of the industry, continuously adapting to meet the diverse needs of varied healthcare systems.
The Challenge
Navigating the intricate web of international regulatory requirements for medical devices can be challenging “Regulatory affairs is a world where the rules are constantly evolving, especially for software medical devices," says Kyle. Language barriers further complicate these efforts, as regulatory documents and communications often require translation and interpretation by experts familiar with local regulations. These challenges highlight the necessity for specialized expertise to handle the regulatory intricacies effectively. "We need expertise that we don’t have in-house, particularly in jurisdictions with unique regulatory landscapes."
To address these challenges, Circle Cardiovascular Imaging partnered with Arazy Group. "Our relationship with Arazy Group started before my time here," Kyle recounts. The initial connection was made through a conference where the VP of Regulatory Affairs Dr. Shirantha Samarappuli, met Benny, the CEO at Arazy Group. "Their expertise in various jurisdictions as having a Canadian based team made them an ideal partner for us." Reflecting upon their longstanding relationship, Benjamin Arazy says, “I recognized a fellow veteran of regulatory affairs; [Dr. Samarappuli] has a deep understanding of what is required to achieve success in this challenging industry.”
When asked why the partnership has worked for so many years, Kyle listed exceptional client support from Arazy Group, highlighting the invaluable assistance of their Client Manager, Matan. Describing him as a "Swiss Army knife" of support, Kyle emphasizes how Matan embodies Arazy Group's core values. “Always ready to assist, he promptly addresses any questions, finding the right person and providing precise answers. His dedication and proactive approach is a value add for us.”
Managing multiple vendors from different countries, each with unique regulatory requirements, is a challenge. Kyle noted, “One standout aspect of our experience has been the proactive approach to informing us about upcoming events and deadlines. Gabi, our current point of contact, excels in this area.”Kyle shared that she reaches out well in advance, often months before deadlines, to provide all necessary requirements through a streamlined portal, allowing Circle’s regulatory affairs team to easily collaborate with the Arazy team until all of the requirements are met. This system keeps Circle on top of renewals and certifications, ensuring they meet all regulatory needs without the hassle of constant email follow-ups. This proactive and organized approach is crucial in navigating the increasingly complex regulatory landscape.
A successful long-term partnership requires mutual respect and cooperation. Gabi, reflecting on her experience with Circle Cardiovascular Imaging, emphasized their organization and punctuality. "They consistently meet deadlines and provide documents and requirements in a timely, high-quality manner," she noted. "Their team is very reasonable, greatly appreciated in this high-stress environment. Most importantly, they are super nice, respectful, and easygoing. Their flexibility and problem-solving approach make them exceptional partners.”
“We do our best work with partners like this! They are organized, reasonable and punctual, and most importantly, they are respectful and easygoing" - Gabriela Marozzini
Kyle appreciates the educational resources provided by the Arazy Group Regulatory team, noting, "The Arazy Group LinkedIn profile has really adapted and grown the last few years to keep up with the demand. The monthly updates about different countries are very valuable, and the YouTube videos are quite informative. Their presence and content on LinkedIn is very approachable.”
Advice for Start-Ups or Scale-Ups with Small Regulatory Teams.
When advising MedTech start-ups or scale-ups on working with a regulatory consultant, Kyle emphasizes two critical points. Firstly, he highlights the advantage of partnering with a single, well-established firm like Arazy Group. “Having one vendor approved for multiple regions significantly reduces the burden on our Quality Management System (QMS). "Instead of managing different vendors for each of our country registrations, we streamline the process through one comprehensive provider. This not only simplifies regulatory compliance but also minimizes administrative overhead.”
Kyle also underscores the value of investing in a reputable consultancy despite the higher cost. He notes, “While the expense of working with a top-tier consultant like Arazy Group may be higher, it ultimately provides better value. We previously worked with other companies where poor communication and inefficient operations outweighed the initial cost savings. In contrast, a firm like Arazy Group offers efficient service and effective management across diverse regions, proving to be a more strategic investment in the long run.”
Circle Cardiovascular Imaging’s journey from a pioneering startup to a global leader in cardiovascular software illustrates the vital role of strategic partnerships in navigating complex regulatory landscapes. Collaboration with Arazy Group has enabled the company to expand its reach and enhance cardiac care worldwide.
The partnership between Circle Cardiovascular Imaging and Arazy Group has proven to be a transformative alliance. By navigating regulatory complexities and overcoming significant challenges, this collaboration has enabled Circle Cardiovascular Imaging to enhance its market presence and operational success. Looking ahead, ongoing projects with Arazy Group promise continued growth and innovation for Circle Cardiovascular Imaging. Kyle aptly states, “Reliable regulatory partners are essential in the medical device industry. Our work with Arazy Group exemplifies the critical role such partnerships play in achieving global success.”
Circle Cardiovascular Products Registered in Multiple Countries
MAKING THE BEST MEDICAL DEVICES AND PRACTICES ACCESSIBLE TO PATIENTS WORLDWIDE AS SOON AS POSSIBLE...
Our approach to achieving this critical goal is by providing a single platform that offers all necessary safety compliance information, registration management tools, and expert support to each function within an organization’s regulatory affairs department and to the other stakeholders involved in bringing products to market.
