1. Understand the regulatory framework of SaMD and AI based devices in Europe & United States, Canada
2. Application of Artificial Intelligence in medical specialties
3. SaMD and AI based classification – Europe & United States, Health Canada
4. Quality Management System for SaMD and AI based organization
5. General hurdles and challenges for regulatory approvals – Design controls, Clinical Evidence, Documentation, Data volume
6. Technical Documentation and preparation for a QMS & regulatory approvals
Software as Medical Device (SaMD) and Artificial Intelligence (AI) are redefining the way we think, forcing us to re-evaluate the medical and healthcare technologies we choose, driving us to re-design and manufacture in the most non - traditional way. These revolutionary approaches are becoming more and more necessary, as a result we have high expectation for their suitability and acceptability. Software as Medical Device (SaMD) or AI/ML implementation in the fields of medical science, medical devices, in-vitro diagnostics, clinical evaluation, healthcare, and pharma is predicted to be one of the most significant technological advances of the decade. That being said, it would present numerous problems and difficulties for manufacturers, healthcare workers, lab experts, doctors, engineers, coders, Quality assurance and regulatory affairs professionals, clinical experts, and regulators on a global scenario.
In this course, which is a 2-part webinar series, we'll focus on the current regulatory requirements, the role of regulatory bodies, the difficulties regulators and manufacturers may face in establishing a system and regulating healthcare devices and applications. Also, we will discuss how to comprehend, control, and ensure the global population benefits from SaMD or AI devices for it to be safe and effective.
Lastly, we will be conducting an exclusive Bring Your Own Challenges session, where we will encourage attendees to have open discussion with the expert on the questions that are pain points exclusively for their organizations.
Quality Assurance Departments
Quality Control Departments
Regulatory Compliance Departments
Research and Development Departments
Medical Device Software Quality Assurance Engineers
Senior Management of Medical Device Software Companies
Sundeep Agarwal is a global Leader, Speaker, Trainer & Consultant in the field of Product Design & Development (PLCM), Quality Assurance & Regulatory Affairs, European CE Certification, US FDA 21 CFR Quality Regulations, Quality Management Systems (QMS), Good manufacturing Practice (GMP), Software as Medical Device (SaMD), Software verification and validation, Artificial Intelligence in Healthcare, Digital health Platforms (DHP), Risk Management, Process Qualification, Research-to-Commercialization and Good Clinical Practice. Currently, he is an active member of a Technical Group (Software as Medical Device) at Global Harmonization Working Party and he is quite knowledgeable with IEC 62304, IEC 60601, IEC 82304, ISO 13485, ISO 27001, etc standards. With more than a decade of experience, his expertise is coveted by industry and professionals alike.