Ramiro Fabian Casas is a distinguished leader in the medical devices regulatory landscape, serving as the Founder and Principal Officer of Huasi Biomedical. With a robust background in regulatory affairs and quality management, Ramiro has established Huasi Biomedical as a pivotal resource for regulators, notified...
Ramiro Fabian Casas is a distinguished leader in the medical devices regulatory landscape, serving as the Founder and Principal Officer of Huasi Biomedical. With a robust background in regulatory affairs and quality management, Ramiro has established Huasi Biomedical as a pivotal resource for regulators, notified bodies, and certification agencies. His firm specializes in providing tailored support to the medical device industry, ensuring compliance with stringent regulations such as ISO 13485:2016 under the Medical Device Single Audit Program (MDSAP), the European Union Medical Device Regulation (EU MDR 745/2017), and the U.S. FDA regulations outlined in 21 CFR Parts 801, 803, 806, and 807.
Under Ramiro's leadership, Huasi Biomedical has successfully forged strong partnerships with government agencies, metrology laboratories, and accredited bodies, enhancing the quality assurance (QA) and regulatory affairs (RA) capabilities of its clients. His strategic approach to regulatory compliance not only maximizes operational efficiency but also fosters innovation within the medical devices sector. Ramiro's expertise in validation and verification (V&V), corrective and preventive actions (CAPA), and ISO standards positions him as a trusted advisor in navigating the complexities of medical device regulations.
In addition to his technical skills, including proficiency in Microsoft Excel for data analysis and reporting, Ramiro's strategic planning abilities enable him to anticipate industry trends and regulatory changes. His commitment to excellence and continuous improvement has solidified Huasi Biomedical's reputation as a leader in quality and regulatory support, making it an invaluable partner for organizations striving to meet the highest standards in medical device safety and efficacy.
