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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Person Responsible for Regulatory Compliance

    This on-demand session summarises the most important elements for a Person Responsible for Regulatory Compliance (PRRC) to consider when carrying out their tasks. Obligations of economic operators, management responsibilities and essential processes for continuous improvement of quality management are revised. This session covers items that are additional to the previous sessions of the Regulatory Essentials in Health Tech training series and completes the qualification for employees assigned with the responsibilities of a PRRC.

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

    Topics

    • Responsibilities and roles of the PRRC and the management according to the MDR and IVDR
    • Tools for continuous improvement: management reviews, internal audits, mock audits, Post-Market Surveillance, trend analysis, etc.
    • Committing key employees and management
    • Audits by authorities or notified bodies
    • Managing the requirements in multiple markets
    • Communication to authorities

    Target group

    Employees assigned with the responsibilities of a PRRC or other responsibilities related to quality management systems, regulatory affairs, and quality assurance. Useful information also for start-up founders.

    Objectives

    • Understand the obligations of the various economic operators.
    • Know the roles and responsibilities of the PRRC and the management.
    • Understand the importance of continuous improvement.

    Additional information

    It is recommended to follow the entire training series of the Regulatory Essentials in Health Tech to gain essential knowledge on the regulatory landscape. Other training sessions by Labquality are also recommended, such as sessions on ISO 13485:2016 for QMS and ISO 14971 for Risk Management.