How Software Is Changing The Use Of And Types Of Medical Devices

In recent years, the classification and regulation of medical device software have become increasingly intricate, with regulatory authorities tightening pathways. This podcast delves into the nuances of software distinctions and their implications on regulator classifications across different markets. Additionally, it examines essential factors for effectively overseeing these products, particularly emphasizing the importance of a robust quality management system.
Speaker Bio: Yervant Chijian is the Director of Team Lead Medical Devices / IVD, Australia, providing expert technical consultancy for Medical Device regulatory compliance in major markets, ensuring efficient market access. He has spent the last 20+ years in the Medical Device field, including both manufacturing and product development. His expertise lies in Regulatory Strategic Planning, particularly in the United States, Europe, Canada, Australia, and New Zealand markets, and in Product Development and Design Controls, specifically in software and with active devices. Coupled with his experience in Manufacturing Processes, Quality Management Systems (ISO 13485 and MDSAP), and Product Lifecycle Management, he brings a comprehensive skill set to support clients navigate through the variety of regulatory pathways and requirements.
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