Training course to software requirements according to IEC 62304
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
III- Risk management requirements
IV- Software development plan
V- Software requirements - specifications
VII- Software - detailed specifications
VIII- Verification, integration and testing
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.
On-site training courses are customised to meet specific business requirements. Contact for costs and further information.