The Standard EN ISO 13485:2016

Course Details

Event Scheduled: On request
Learning Mode: Online
Language: English
(see more details below)

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Learning Objectives

• Learn and place the ISO 13485: 2016 in the current regulatory environment, including the comparison with the A11:2021 edition.
• Provide an overview of the mandatory applications of ISO 13485:2016 with respect to the various international regulations in medical device field (MDSAP program, FDA, European Regulations etc.).
• Learn the differences between ISO 13485: 2016 and ISO 9001: 2015

Who will benefit?

Quality Management System professionals in organizations operating in the medical device industry.

Course Agenda

• Introduction
• General overview of the current international regulatory environment, including correlation with European regulations on medical devices (MDR / IVDR) and MDSAP program
• What's new in version ISO13485:2016 A11:2021
• Correlation with ISO 9001:2015: differences and additions
• General structure of the standard
• Exclusions and non-applicability
  • Main aspects of ISO 13485:2016
  • process approach
  • focus “regulatory”
  • documentation requirements
  • resource management
  • risk management
  • product/service realization
  • analysis of data
  • monitoring and improvement
• detailed contents of ISO 13485:2016

Prerequisites

Basic knowledge of ISO 13485:2016 and medical device regulatory requirements. It is advisable to have attended an introductory course on the ISO 9001 standard.

Learning Assessments

• Certificate of competence, in case of successful completion of final exam
• Certificate of attendance, in case of non successful completion of final exam or no exam

Teaching Materials

• Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
• Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.

Duration

1 Day.

Scheduled Events

• Events will be planned on request (and published on this page).

Price

610,00 € (per participant, taxation excl.)

Learning Mode

Online, Instructor-Led

Language

Training in English Language

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