ISO 13485 course

Course description

This course is designed to provide participants with understanding of the EN ISO 13485 requirements for sterile medical devices and compliance with MDR 2017/745.

This training provides an in-depth knowledge of the EN ISO 13485 requirements and study cases.

 

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Learning objectives / course outcomes

On completion of this training, participants will be able to:

• Identify the links between ISO 13485and MDR 2017/745

• To understand the requirements from ISO 13485

• Define the requirements for Quality Management System

• Understanding how to implement appropriately the requirements

 

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Who is the course suitable for?

• Regulatory and quality managers and personnel

• Design and development managers and personnel

• Personnel working in the medical device industry

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Course outline

1. Introduction to ISO 13485

2. Quality Management System (QMS) Requirements

3. Risk Management

4. Design and Development Controls

5. Supplier and Purchasing Controls

6. Production and Process Controls

7. Corrective and Preventive Actions (CAPA)

8. Internal Audits and Management Review

9. Regulatory Requirements

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Prerequisites

 There is no pre-requisite to this training.

 

What format does the training take?

MDSSPRO uses interactive teaching techniques, keeping the course varied and stimulating through exercises, working applications and case studies.  Experienced and knowledgeable industry-leading tutors ensure individuals stay engaged throughout the course and that the learning objectives are met.

 

The course can be run online or onsite at company offices.

 

MDSSPRO’s online training course is powered through a Performant Software platform. Online tutors are available throughout the length of the course offering full support to course participants, answering questions, offering advice and explaining course material as required. 

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Price

We are providing online training course for £300 per person on our platform https://mdsspro.talentlms.com/index. The content is available for 3 months after registration.

A certificate is delivered after completion of the training. Want to start now? Press the button

On site training is tailored by on your needs. For more details contact office.mdsspro@gmail.com