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    Free webinar – What has changed for the IVD industry after EU IVDR - Challenges and implementation

    Presenter (in English): Sundeep Agarwal

    Sundeep Agarwal
    Webinar designed for all stakeholders involved in the process of adherence to the European Commission’s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017/746) requirements. That includes manufacturers, suppliers, notified bodies, competent authorities, authorised representatives, importers, etc. Globally, from 26th May 2022 IVD, manufacturers will have to comply with the EU IVDR. Gear up for the next level and execute accordingly.

    Language: English

    Format: Recorded webinar

    Duration: 67m 30s (1h 7m 30s)

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    Register for this webinar to learn:

    • Key changes due to IVDR
    • Need for a QMS
    • New product classification
    • Essential role of notified bodies
    • CE certification process
    • Supplier & sub-contractors management
    • Unannounced audits
    • Performance evaluation plan & report

    Target audience:

    This training is designed for technical employees related to quality, regulatory, supply chain, and clinical, including:

    • Director/VP – Quality/QMS/ Regulatory Affairs
    • COO – Strategic Planning
    • Regulatory/Quality Affairs Head
    • Quality Assurance Manager
    • Manufacturing or Production Head
    • Quality Assurance Engineers
    • Quality Control Officers
    • Quality & Regulatory Affairs Specialists
    • Regulatory/Quality Associates
    • Regulatory Consultants
    • Clinical or Medical Writers

    Presented by: Sundeep Agarwal

    Sundeep AgarwalWith a Master of Technology in Quality Management and a decade of experience in medical and IVD devices & life sciences, Mr. Sundeep Agarwal is a leader, speaker, trainer, and consultant in the fields of Quality Assurance, Regulatory Affairs, QMS, Software Validation, Artificial Intelligence, Combination Devices, GCP, Design & Development, Risk Management, and Industrial Manufacturing. He is a lead auditor for medical devices and has expertise in ISO 13485, EU MDR, IVDR, CE Certification, CER, PMS, USFDA, 510(K), ISO 14971, and MDSAP.

    Mr. Agarwal has delivered multiple global webinars on medical/IVD devices and life sciences topics. He is also a prominent guest lecturer at various MBA and pharmacy educational institutions in India and an active member in a Technical Group in the Asian Harmonization Working Party.

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