Thanks to advances in medical technology, millions of patients change their life for the better. Competitive technology companies are innovating and producing better medical devices.
In the rapidly evolving landscape of medical device development, adhering to international quality standards is paramount. Among these standards, ISO 13485 stands out as a crucial framework that ensures the highest level of quality and safety for medical devices.
At the core of SIC Academy Commitment to excellence is the ISO 13485 training program. This international standard, tailored for organizations engaged in medical device development, provides a systematic framework for maintaining the highest standards of quality management.
A serial entrepreneur and inventor was involved in the development of the curriculum – Ilya Popov, President of СBM company.
His forward-thinking approach underscores a focus on innovation in healthcare, a commitment that goes beyond creating the latest medical devices and results in an entrepreneurship culture that values the quality and safety of healthcare solutions.
Mr. Popov recognizes ISO 13485 as more than just a set of guidelines, but as a tool for ensuring the safety, effectiveness and compliance of medical devices.
As the inventor of a revolutionary medical device, he understands that innovation and adherence to standards are not mutually exclusive.
The innovative spirit of a practicing developer, combined with the years of experience of SIC Academy mentors, has become the basis for upgrading the curriculum for a vast array of students who will improve the international healthcare ecosystem.
Thus, in the certification scheme, being developed jointly by the Council of the Technical Committee of the SIC Academy and the entrepreneur Mr. Popov, an exam at the end of the course is to be used for the first time on the
“Design control system-FDA standard, and GMP (Good Manufacturing Practice)”.
Our joint project includes the application of methodologies for measuring risks associated with medical device design; a topic that Mr. Popov knows well from both theoretical and practical points of view.
Ilya Popov has greatly enriched SIC Academy by introducing us to new techniques and helping us gain a more comprehensive understanding of risks, design of Requirements Traceability Matrix (RTM) in various situations and applications.
To learn more about Mr. Ilya Popov and his company visit comebackmobility.com