After a thriving career in different Regulatory and Quality roles in start-ups and Fortune 500 companies, Hasnaa started her own business, QARALOGIC Consulting Inc., to help companies bring their medical innovation to patients in need.
Hasnaa is a RAC (Devices) holder, a certified (BSI) 13485:2016 Lead Auditor and a qualified PRRC (person responsible for regulatory compliance) for the EU-MDR/IVDR transition. In addition to the EU regulations, Hasnaa supports companies with low to medium risk marketing applications in the US, Australia and Canada.
Hasnaa moved to Taipei, Taiwan in January 2020, where she opened a branch office of her boutique consultancy business and has been a very active of the local MedTech/Digital Health community.
Taiwan's ICT industry is undeniably strong. In the past years, and exacerbated by the Covid-19 pandemic, new trends started emerging whereby more Taiwanese ICT companies are developing medical devices or related healthcare services. At the same time, several new government policies such as the "5+2 Innovative Industries" and the "6 Core Strategic Industries" plans place Bio-medicine, Smart Healthcare and Digital Transformation have at their heart.
While Taiwan has every reason to succeed in the shift from ICT to Healthcare, this move is not a straightforward one. In reality, most ICT manufacturers are not acquainted with the healthcare industry idiosyncrasies, not to mention Taiwan's dependence on export. This makes it even more crucial to manufacture and sell devices designed with global regulators and users in mind.
In this presentation, practical insights on the medical device industry will be shared with an emphasis on key regulatory requirements and organizational culture as indispensable strategies to success in the MedTech industry.