This 1.5 day training course gives participants an in-depth knowledge of IEC 62304 requirements and its application.

 

By the end of the course, participants will be able to:

• Identify the links between MDD/ MDR and IEC 62304

• Explain how the requirements relate to the product lifecycle

• Define the software requirements

• Define the classification of the software

• Define the key documents of the risk management file

• Define the key deliverables for software validation

 

Who is the course suitable for?

• Regulatory quality managers and personnel

• Design and development managers and personnel

 

Course outline

I- Introduction

II- Classification

III- Risk management requirements

IV- Software development plan

V- Software requirements - specifications

VI- Architecture

VII- Software - detailed specifications

VIII- Verification, integration and testing

IX- Maintenance

X- Configuration management

XI- Software problems - resolution

 

Prerequisites

Participants should have a basic knowledge of:

-  ISO 14971 and quality management systems and/or

-  the medical device industry

 

Price

Online training course - £450 per person. We also offer this training at a special price for student, for more details contact us at admin@mdsspro.com. 

 

On-site training courses are customised to meet specific business requirements.  Contact admin@mdsspro.com for costs and further information.