Manil Asija
About Manil Asija
Manil Asija is the Director of Design Quality Assurance at Butterfly Network, Inc. in Greater Boston, with extensive experience in quality systems and regulatory compliance across the medical device and healthcare industries.
Title
Manil Asija serves as the Director of Design Quality Assurance at Butterfly Network, Inc. He operates out of the Greater Boston area.
Professional Experience at Butterfly Network
Manil Asija currently works at Butterfly Network, Inc. as the Director of Design Quality Assurance. In this role, he leads quality assurance teams managing a portfolio of regulated products. His primary focus is ensuring these products meet stringent agency approval standards, specifically concerning regulations like ISO 13485, CFR Part 820, Part 11, IEC 62304, and HIPAA/GDPR.
Previous Roles and Experience
Manil has held multiple significant positions in quality systems and regulatory compliance across various prominent organizations. At Boston Scientific, he handled Global Quality Systems for Digital Technologies. During his tenure at IBM, he was the Lead in Design Quality and Regulatory Compliance for IBM Watson Health. He also managed global device quality projects at Sanofi and quality projects at HeartWare Inc. Other previous roles include Global Integration Project Manager at Haemonetics, Software Quality Engineer at Fresenius Medical Care North America, Quality Systems Software Engineer at Boston Scientific, and Sr. Software Engineer V&V at Siemens Healthcare.
Education and Expertise
Manil Asija earned a B.Sc in Computer Science from Kurukshetra University, where he studied from 1993 to 1996. His expertise spans the development of regulated products such as Software-as-Medical-Device (SaMD) and Digital Health systems. He has extensive experience ensuring these products comply with industry regulations and standards. Manil excels in leading quality assurance teams, managing compliance projects for cloud platforms, and Digital Health applications with advanced AI and analytics capabilities.
Regulatory and Compliance Leadership
Manil Asija’s work ensures compliance with a range of critical regulations such as ISO 13485, CFR Part 820, Part 11, IEC 62304, and HIPAA/GDPR. He maintains a Global Quality Management System (QMS) to adhere to regulatory, privacy, and security standards. Manil supports both internal and external audits, including certification audits. Additionally, he represents Butterfly Network as a member of the Software Working Group by AdvaMed, an association dedicated to advanced medical technology.