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.”
“Everyone knows that an audit is not an easy process, and MSECB made it smooth. The MSECB team was very responsive, and all the answers to our questions were very clear and helpful.
We also felt that our company and our needs and ways of working were well understood. All the suggestions for improvement made perfect sense for us and were easy to put in place and get the buy-in of our employees”
“Protecting our customers and enhancing quality management has always been a priority for BIOS Middle East. Achieving ISO 9001, ISO/IEC 27001, ISO/IEC 27017, and ISO/IEC 27018 certifications provide independent assurance of our commitment to leverage the latest best practices and security controls around all our services.”
“It is important for an organization to get ISO 9001:2015 certification, to achieve efficiency in service delivery, and attain maximum customer satisfaction.”
“The ISO 9001:2015, ISO 45001:2018, and ISO 14001:2015 certifications are mostly a pre-requisite to participate in most major International EPC Tenders of large multi-national & government projects and very crucial in winning large clients. Following the decision to scale the business outside of Ghana, it was imperative that we get ISO certified.
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.”
“By achieving ISO/IEC 27001 Tr3dent demonstrates commitment to provide our customers and partners with a level of information security conformity that meets the highest industry standards and secures our clients’ data accordingly.”
“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.”
“Security within an organization belongs to everyone, and it requires the full effort of a team. Being audited and having conformity with the requirements for ISO/IEC 27001 and ISO/IEC 27701 certifications was and remains to be an opportunity to reinforce our commitment to data privacy and security not only for the customers and partners we serve, but in our company-wide culture.”
“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.”
“The ISO 37001 certification process has been a starting point to drive organizational change and redefine trust within the company, as well as a good opportunity to provide extensive anti-bribery training to employees.
Setting the goal to achieve ISO 37001 certification has been the trigger to implement a program meant to raise awareness and increase preventive measures. Since its beginning in 2015, this program has intensified each year and will continue indefinitely.
This certification acknowledges our model of responsible business conduct, based on full compliance with the rules and on zero-tolerance approach towards bribery. It also proves that UTI’s compliance program is mature and effective in preventing and detecting bribery-related misconduct and has the means to routinely assess the effectiveness of the anti-bribery regulations and continually improve them over time.”
“ISO/IEC 27001: To become more productive and ensure information security effectiveness.”
“By achieving ISO 9001 and ISO/IEC 27001 certifications, ELEKS has shown its commitment to quality and information security, ensuring that all the necessary controls are in place, and that its people, the technology, and their processes have met the requirements of these standards. The certifications assure clients and partners that ELEKS prioritizes robust quality, security and reliability in its delivery and management processes.”
“Being a leading pure cyber security company, we had to comply with high standards of information security and quality to strengthen our corporate responsibility and sustainability. The ISO/IEC 27001 and ISO 9001 certifications allowed us to raise our trustworthiness and reliability vis a vis our stakeholders as a cyber security service provider of reference in the region.”
“For Alter Domus, achieving ISO/IEC 27001 and ISO 22301 certification demonstrates to our customers and all interested parties that our information security and business continuity management systems operate to the highest industry standards.”
“Achieving ISO/IEC 27001:2013 certification further strengthens the deep trust we have built with our customers and partners, as well as further protecting our brand and enhancing our operations.”
“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.”