Training course to software requirements according to IEC 62304

Course description

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


It guides organisations through the regulatory requirements for:

  • embedded software for active medical devices

  • standalone software for medical devices


It focuses on MDR and MDD compliance and explains how businesses can guarantee safety claims of medical devices.


Learning objectives / course outcomes

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



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. 


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


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

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