Software requirements course
Course Overview
Software Requirements Course (Mastering IEC 62304 - Compliance for Software)
This training course provides attendees with a complete understanding of the IEC 62304 standard and the requirements to develop software in a medical device environment. The course provides an overview of the regulatory requirements under the MDR and UK MDR 2002 and enables your organisation to achieve full compliance, whilst enhancing the software’s safety, documentation, and lifecycle management.
Attendees will receive clear insight into how software fits within the wider medical device regulatory environment, and how to manage classification, validation, and risk, to ensure quality expectations are met globally.
- Understand the relationship between MDR/UK MDR 2002 and IEC 62304
- Explain how software requirements integrate into the product lifecycle
- Recognise and differentiate software classifications
- Apply risk management principles to software development
- Identify risk management documents and deliverables
- Appreciate the important steps in software validation
Learning Objectives / Course Outcomes
On completion of the training, attendees will be able to:
Course Summary
- I. Introduction - Overview, course goals, and international context
- II. Classification - Understanding software safety classes defined in IEC 62304
- III. Risk Management Requirements - Incorporating principles of ISO 14971 into the software development process
- IV. Software Development Plan - Structuring and documenting the software development process
- V. Software Requirements - Specifications - Writing clear and compliant software requirements
- VI. Architecture - Building a solid framework for safe software design
- VII. Detailed Software Specifications - Management of traceability and change control
- VIII. Verification, Integration, and Testing - Confirming software performance and reliability
- IX. Maintenance - The management of updates and post-market changes
- X. Configuration Management - The control of versions, baselines and releases
- XI. Software Problem Resolution - Management of issues, incidents and CAPA processes
Prerequisites
Attendees are expected to have a working knowledge of:
- ISO 14971 and Quality Management Systems, and/or
- The medical device industry and its regulatory framework
Training Format
The course is available in both online and onsite formats to suit your organisation's preference.
- The training format consists of a mixture of interactive exercises, case studies and real-world scenarios to support your application of learning. Courses are facilitated by experienced tutors with extensive knowledge in the MDR, software validation and regulatory compliance.
Online Course - £450 per individual
Online Course: £450 per person
- Student Discount: Available upon request — contact admin@mdsspro.com
- On-site Courses: Customised to meet your specific business requirements. Contact admin@mdsspro.com
Who Should Attend?
This course is suitable for anyone involved in software and compliance for medical devices, including:
- Regulatory and Quality Managers
- Design and Development Engineers
- Software Engineers
- Project Managers responsible for validation and documentation
Online Course - £450 per individual
Includes a dedicated online tutor, live Q&A sessions and practical exercises.
Online Course – £450 per person – Includes access to an online tutor, live Q&A sessions, and practical exercises. You may be eligible for a student discount – contact admin@mdsspro.comfor more information
On-Site Course – Customised Training –
Delivered according to your company’s software products and regulatory requirements.To find out more information or to request a quote, contact admin@mdsspro.com
Gain confidence in software compliance-MDSSPRO will work with you to reinforce your understanding of IEC 62304 to achieve the highest safety and quality standards for medical device software. Our training courses will assist you in achieving compliance with confidence – from conception to maintenance.
Let’s Build Compliance Confidence Together
Partner with MDSSPRO to ensure your medical devices meet the highest regulatory standards. From tailored training to expert auditing, we’re here to guide you every step of the way toward full MDR compliance.
