Sisu Global Health
Not only is ISO 13485 Certification a validation of the high standards that Sisu Global follows in our quality procedures to ensure a safe product, but it has also been critical in our expansion. ISO 13485 is recognized as a global standard and being certified with this standard, has opened up new global markets for our novel autotransfusion device, Hemafuse.
– Carolyn Yarina,
CEO & Co-founder of Sisu Global Health
About Sisu Global Health
Sisu Global is an American ISO 13485 certified company that designs medical devices for emerging markets. Since its beginning in 2014, Sisu Global’s mission is focused on increasing blood access by enabling clinicians to use a patient’s own blood to save them with a medical device that has the ability to operate anywhere there is a surgeon.
Sisu Global has 3 issued patents with the U.S., international coverage, and has been recognized by the US Patent Office with a Patent for Humanity. They are also currently in the process of expanding sales from Kenya and Ghana into new geographies.
Why did you choose to get certified against ISO 13485?
ISO 13485 allows Sisu Global to provide safe and effective products to emerging markets, globally. It has helped us meet an international standard, assisting in the expansion of our product within Kenya and Ghana by meeting regulatory requirements, and helped us establish a quality management system for medical device development.
What are the main benefits of your company after the implementation and certification against ISO 13485?
ISO 13485:2016 has given Sisu Global access to new markets. As a start-up company, this implementation and certification against ISO 13485:2016 has helped us ensure our framework to design and develop medical devices that consistently meet customer requirements across the life-cycle of our devices. The certification has supported Sisu Global in expanding into emerging markets with life-saving emergency medical devices such as the Hemafuse.
About your experience with MSECB
“Working with MSECB was an overall positive experience – they provided flexibility of remote audit during the COVID-19 pandemic. Our auditor was skilled, competent, and personable.”
Other Testimonials
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Beyond the standard audit, the auditor’s value-added insights specific to the security industry further strengthened our resilience. Throughout the process, MSECB’s supportive customer service was outstanding; consistently responsive, approachable, and helpful.”
“One of Paystack’s core values is “Insist on high standards” which reminds us that merchants trust us with their livelihoods. As such, we give this responsibility our absolute best. At Paystack, we seek to be the reliable industry experts that our merchants and partners can count on, especially in areas critical to their operations like privacy and security. By adhering to the rigorous ISO/IEC 27001 and ISO/IEC 27701 standards, we are not only able to maintain top-tier security and privacy practices but also champion these standards throughout the fintech ecosystem.”
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Throughout the certification process, MSECB showcased a commitment to quality which was greatly valued.
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“Exclusive Capital’s journey through the ISO/IEC 27001 certification process with MSECB was characterized by a meticulous verification aligning with global standards.
Our experience with MSECB was exceptionally positive and professional. The auditing process stood out for its thoroughness, organization, and attention to detail. MSECB’s customer service was commendable, featuring responsive and knowledgeable staff facilitating a seamless certification process.
Our overall collaboration with MSECB reflected professionalism, expertise, and a shared commitment to upholding the highest standards in information security.
We value this partnership and eagerly anticipate continued collaboration.”
“Our audit and certification experience with MSECB was exceptional. The auditing process was thorough yet collaborative, with MSECB demonstrating expertise and professionalism. Their customer service was commendable, providing clear guidance and prompt responses. The partnership with MSECB has facilitated a seamless certification journey and reinforced our confidence in their commitment to excellence and the high standards upheld by their team.”
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“At Interswitch, ISO 22301 certification represents our unwavering commitment to resilience, dedication to business continuity, and profound understanding of the significance of preparing for the unexpected.
ISO 22301 certification is a proactive approach to risk management that demonstrates to stakeholders and customers that we at the Switch prioritize the continuity of our operations, even in the face of adversity. It is not just a mark of achievement; it shows the Switch’s ability to weather storms and emerge stronger on the
other side.”
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“GET Group, a leading provider of identity management and security solutions has shown its commitment to quality and information security by being ISO 9001 and ISO/IEC 27001 certified. These certifications enhance trust and reliability amongst our customers and partners, enhancing our day-to-day operation and protecting our assets.”
Mrs. Maysoon Jamal – Chief Executive Officer at GET Group Holdings
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“The ISO/IEC 27001 certification is a crucial step to continually improve our information security and protect the data that our customers entrust us with.”
“MSECB immediately responded to any request and was instantly available to offer their help and support. They have a good understanding of customers’ needs and excellent client orientation.”
“DAZN had an excellent experience with MSECB. The auditors were well prepared, with a high degree of knowledge of the ISO/IEC 27001 standard.”
“The high professionalism of the auditors and back-office employees, prompt assistance and excellent quality made our choice very simple. We are sure that when we chose MSECB we made the right choice.”
“The experience was rigorous and educating. The customer service is top notch.”
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“Our journey to ISO/IEC 27001 certification was surprisingly straightforward. Our auditors explained the process in advance, and we were able to meet the proposed schedule, which was much appreciated.”
“We had a great audit and are excited that we passed the assessment. The auditor was well experienced and MSECB
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The process has ultimately allowed us to boost the quality of our work/services, increase the satisfaction of our customers, and enhance the productivity and operational efficiency with the hope that it will set us apart from our competition.”
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“Vision 2030 has been inspiring us to achieve an unprecedented step in the field of cybersecurity in line with the Kingdom’s aspirations to be one of the best cybersecurity leaders in the world.
Following our successful certification against ISO/IEC 27001:2013 and ISO 22301:2019, we consider ISO/IEC 27032:2012 certification as an additional step towards the achievement of our strategic goal to integrate the highest standards of cybersecurity and information security procedures.”
“Not only is ISO 13485 Certification a validation of the high standards that Sisu Global follows in our quality procedures to ensure a safe product, but it has also been critical in our expansion. ISO 13485 is recognized as a global standard and being certified with this standard, has opened up new global markets for our novel autotransfusion device, Hemafuse.”
“For us at Viseven, the ISO/IEC 27001 certification is a staple of corporate responsibility: it confirms our compliance with our customers’ information security requirements, as well as those of applicable legislation, all of which is engrained in our corporate DNA as part of the digital culture as a tech company.”
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“In one hand, MSECB customer service team proved their values by being really professional and keen on their approach. They were always ready and willing to support us with any clarity related to MSECB services. On the other hand, MSECB auditor/s showed a great maturity and competence at handling the entire certification audit process independently end-to-end. We highly recommend you to consider MSECB as your certification body so you can live a great experience”
“Certifications enable accountability by aligning technology, processes, and people to respond to imperatives regarding governance, risk, and compliance – or in other words, they demonstrate our trustworthiness through the lenses of an independent third party.”
