ISO 13485: Quality Management in the Medical Device Industry

ISO 13485 is the international reference standard for Quality Management Systems in the medical device industry. Understanding its principles is essential for ensuring compliance with regulatory requirements and contributing to the quality and safety of products [...]

Date

11 September, 2026

Registration Deadline

4 September, 2026

Format

Live Streaming

Language

Italian

Price

€420 for non-clients
€315 for clients — VAT excluded

This course provides an overview of the main requirements of the standard and their impact on company activities. At the end of the training, participants will have acquired the basic knowledge needed to understand how an ISO 13485-compliant Quality Management System operates and their role in ensuring its effectiveness.

Key Points

  • Introduction to the ISO 13485:2016 standard

  • Scope and structure of the standard

  • Detailed content of the standard

  • Implementation of an ISO 13485 QMS

Structure

  • 4-hour course. (9.30 AM – 13.30 PM)

  • Certificate of partecipation

The course will be confirmed when reaching a minimum number of participants.

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