Training course to software requirements according to IEC 62304

Course description

This 1 day training course gives participants an in-depth knowledge of IEC 62304 requirements and its application.

Learning objectives / course outcomes

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

Identify the links between UK MDR/ EU 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

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.

Price

We are providing online training course for £500 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.

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