Regulatory: Med Dev regulation

This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.

Dive into the core principles of risk management using ISO14971:2019. Learn to assess, analyse, and mitigate risks effectively, ensuring compliance with international standards and enhancing decision-making in various industries.