Software Requirements

Medical device software requirements

Software Requirements is a 1.5 day training course which 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 compliance and explains how businesses can guarantee safety claims when it comes to medical devices.  To enquire, contact Medical Device Software & Sterilization Professionals in Lee-on-the-Solent today.  We offer the course throughout Hampshire and worldwide.

Learning objectives / course outcomes

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

  • Identify the links between 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 use interactive teaching techniques and keep the course varied and stimulating through exercises, working applications and case studies. Experienced and knowledgeable industry-leading tutors lead the course and ensure individuals stay engaged and that 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 and offer full support to course participants - answering questions, offering advice and explaining course material as required. 

Price

Online training course - £450 per person. We also offer this training at a special price for students, 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.
If you have any queries about our Software Requirements course, please email
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