Optimize your Quality System for Software as a Medical Device (SaMD) скачать в хорошем качестве

Optimize your Quality System for Software as a Medical Device (SaMD)

At IME South 2022 in Charlotte, NC this year our Executive VP of Medical Device and CTO, Seyed Khorashahi hosted a tech talk about SaMD and your Quality Management System. We provided a brief overview of what software as a medical device (SaMD) is and then took a look at what is needed to Optimize a Quality System for a SaMD. We also touched on the different risk categories associated with SaMD as well as the Clinical Evaluation and regulatory submission. We Will Cover Optimization of Quality Management System for SaMD products from inception to retirement and its alignment to ISO 13485 SaMD Realization and Use utilizing IEC 62304, AAMI TIR 45 Life Cycle Support Processes Intended purpose of the SaMD (Treat/Diagnose, drive clinical management, or inform Clinical management and its impact on device classification Submission documentation requirements for SaMD algorithm (Traditional or AI / ML) Clinical evaluations, validations, and submissions About RCA Regulatory Compliance Associates®  (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges: Pharmaceutical Biologic & Biotechnology Sterile compounding Medical device Lab Testing We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.