News

We are one step closer to achieving a crucial goal – obtaining FDA certification. In our unwavering commitment, we have reached a new milestone. We have successfully undergone a highly significant electromagnetic compatibility (EMC) compliance study, basic safety tests, and performance evaluations conducted by one of ASCA-accredited research laboratories (UL Solutions). The studies were conducted in accordance with rigorous medical device standards (ISO 60601-1, ISO 60601-1-11, ISO 60601-1-2, ISO 60601-2-37), fully confirming that the Pregnabit Pro devices and PregnaOne platform have received full compliance confirmation. This signifies that we fulfill the additional requirements necessary to obtain approval from the U.S. Food and Drug Administration (FDA) to introduce modern patient care methods through Nestmedic products for use by American doctors and, above all, their patients. Obtaining FDA certification will enable Nestmedic to commercialize its offerings in the American market. The value of telemedicine services in the United States is estimated to exceed $150 billion USD by 2030, indicating a strengthening trend in telemedicine. It’s worth noting that in 2022, North America held a 36% share in the global telemedicine market, corresponding to nearly $23 billion USD. Nestmedic remains committed to meeting all formal requirements aimed at initiating sales in the USA, thereby aligning with this growing trend. We continue to strive for providing access to innovative solutions for women’s health worldwide.

We are celebrating success of our Quality and Regulatory Affairs Director, Anna Szopa! She has successfully completed the “Lead Auditor for Medical Devices Quality Management System ISO 13485:2016” course. The certification, accredited by CQI/IRCA and conducted by BSI Group Polska, showcases her expertise in this standard and auditing quality management systems in the medical industry. Continuous improvement is a crucial aspect of ISO 13485:2016 quality management system, achieved through internal audits. At Nestmedic, we conduct audits not only internally but also on suppliers. Having competent and experienced personnel with auditing credentials is essential for us. Our internal audit team has completed training from reputable providers, but to further enhance audit quality, we decided to invest in the development of our team. This certification strengthens our auditing capabilities and ensures the continuous improvement of our quality management system. Congratulations, Anna!

We stand in solidarity with Ukraine. Our support continues unabated – we are donating more Pregnabit devices – 15 this time – to a hospital in Ukraine, free of charge and in perpetuity, to help health workers work during the conflict. Our commitment to the welfare of mothers and unborn children remains unwavering. Together, we can bring hope and care to those most in need.