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Curso Q-77 Norma ISO 13485 para la gestión de la calidad en organizaciones de productos sanitarios

Live Training Presencial In Company
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Las empresas que intervienen en cualquiera de las etapas del ciclo de vida de los productos sanitarios o de servicios relacionados con los mismos, deben tener en cuenta tanto los requisitos asociados a la gestión de la calidad como los requisitos reglamentarios. Basándose en ISO 9001, la norma ISO 13485 proporciona a las empresas el marco necesario para implantar un sistema de gestión de la calidad que asegure que sus productos y servicios cumplen tanto los requisitos del cliente como los reglamentarios aplicables.

En este curso se explican los requisitos de la norma ISO 13485 como base para la implantación de un sistema de gestión de la calidad y cómo aplicarlos a las empresas de productos sanitarios.

Intended for

Professionals from companies that design, manufacture, install and service medical devices, or that provide related services, as well as companies that distribute or use them.

We recommend that participants in this course have prior knowledge of the requirements of the ISO 9001 Standard

Requirements

It is recommended that those attending the course have prior knowledge of the requirements of the ISO 9001 standard.

Special promotion

*Discounts cannot be combined.

Objectives

- Be familiar with applicable laws on medical devices
- Understand the importance of managing quality in medical device companies
- Analyse the requirements of the ISO 13485 standard. Medical devices. Quality Management Systems. Requirements for regulatory purposes, including the requirements in European regulations.

Content

1. Medical devices. Definition of the concept
2. Legislation applicable to medical devices. European regulations
3. Classification of medical devices. Conformity assessment
4. Analysis of the requirements in the ISO 13485 standard
5. Critical points: risk management and change control in the system and product. Validation of quality software, manufacture and measurement instrumentation. Tracking. PMS Feedback
6. Management of critical suppliers and subcontractors
7. Implementing a quality management system in medical device companies
8. Case studies

Live Training/Streaming

Aula virtual

03/06/2024 - 04/06/2024

725 + IVA 21%

Call description

Description of format

AENOR offers you all the technologies and resources you need to continue with your training plans and build your future. AENOR has created LIVE TRAINING to allow students to attend the course remotely from home or work.

The courses are taught on a tele-training platform with the simultaneous presence of teachers and students interacting in the Virtual Classroom throughout the training session.
During the duration of the course, the teacher presents the subject by videoconference, with practical examples and taking into account the students' queries and questions.
The teacher combines theory classes with collaborative team activities, which gives students the opportunity to learn and acquire knowledge with the same quality as in-person training.

The best LIVE training in your own home with the best teachers.

Classes 100% LIVE.

Schedule

2 days - 14 hours. From 9.00am to 2.00pm and from 3.00pm to 5.30pm
Dates: 03/06/2024 - 04/06/2024

Intended for

Professionals from companies that design, manufacture, install and service medical devices, or that provide related services, as well as companies that distribute or use them.

Requirements

Attendees are required to be familiar with the contents of the ISO 9001 standard.

Special promotion

*Discounts cannot be combined.

Students will receive

The current version of the standard UNE-EN ISO 13485 Medical devices.Quality Management Systems. Requirements for regulatory purposes.

Observations

This course is not eligible for subsidies, as it does not meet the characteristics set out in the Royal Decree-Law regulating the FUNDAE subsidy system.

Live Training/Streaming

The best LIVE training in your own home with the best teachers.

Classes 100% LIVE.

Duration, schedule

2 days - 14 hours. From 9.00am to 2.00pm and from 3.00pm to 5.30pm

Price

€725 (Taxes not included)

On-site

Our facilities are designed to facilitate learning, in a modern and collaborative space. The location of the facilities is very well communicated by metro, train or bus.

Our courses are very practical and face-to-face training facilitates learning by applying knowledge through group work. It also makes it easier to communicate personally and to network with teachers and other students.

Coffee and work lunch is included in the in-person course.

AENOR guarantees compliance with the necessary health measures at all times.

Duration, schedule

2 days - 14 hours. From 9.00am to 2.00pm and from 3.30pm to 6.00pm

Price

€725 (Taxes not included)

FUNDAE allowance In-company training