Medical Device Software Trainings
We offer trainings on medical device software standards: IEC 62304, IEC 82304-1, IEC/TR 80002-1.
And trainings on Cybersecurity in Medical Device Lifecycle: IEC 81001-5-1, IEC/TR 60601-4-5, and FDA Guidances.
Please contact us: mitch{at}md101.io
IEC 62304 training program
Duration: 1 day
Course Outline:
- Introduction.
- History of software standards in medical devices.
- Terms & definitions
- General Requirements, software safety class
- Software Development Process
- Software Risk Management process
- Configuration Management process
- Problem Resolution process
- Software Maintenance process
Learning Objectives
- Knowing main goals of the IEC 62304 standard.
- Knowing IEC 62304 requires throughout the lifecycle of software.
- Understanding how IEC 62304 integrates Risk Management activities.
- Knowing what documents you should write to prove compliance to the standard.
Who should attend?
People working for medical devices or in vitro diagnosis manufacturers:
- Quality Assurance and Regulatory Affairs Managers,
- Software Project Managers,
- Software Development, Risk Management, and Test Engineers.
The training course can be adapted to:
- manufacturers of class C software, with deeper review of class C requirements and use of IEC/TR 80002-1,
- manufacturers with AI/ML software, with interpretation of IEC 62304 requirements for AI/ML,
- attendees more qualified in QA/RA matters or attendees with a more technical background.
IEC 82304-1 training program
Duration: 0.5 day
Course Outline:
- Why IEC 82304-1, Scope
- Relationships with other standards: ISO 13485, ISO 14971, IEC 62304
- Software Requirements
- Software Validation
- Requirements on Instructions for Use
- Requirements on Post-market
Learning Objectives
- Understanding how to apply IEC 82304-1 standard,
- Knowing what documents you should write to prove compliance to the standard.
Who should attend?
People working for medical devices or in vitro diagnosis manufacturers:
- Quality Assurance and Regulatory Affairs Managers,
- Software Project Managers,
- Software Development, Risk Management, and Test Engineers.
Cybersecurity in Medical Device Lifecycle and IEC 81001-5-1 training program
Duration: 1 day
Course outline
- Cybersecurity and FDA, MDR, IVDR regulations,
- Cybersecurity risk management process AAMI SW96, AAMI TIR57, and interaction with ISO 14971,
- Secure software development lifecycle according to standards IEC 62304, IEC 81001-5-1 and FDA guidances,
- Secure software maintenance according to standards IEC 62304, IEC 81001-5-1 and FDA guidances
Learning objectives
- Knowing the concepts of cybersecurity applied to medical devices,
- Knowing which standards are applicable to cybersecurity in Medical Device 2017/745/EU Regulation and US FDA,
- Understanding how to implement cybersecurity processes compliant to these standards.
Who should attend?
Important prerequisite: Experience in IEC 62304 and medical device regulation for software is mandatory.
- Project managers
- Risk Managers
- Quality assurance specialists
- Regulatory affairs specialists
- Software development teams
Published on Tuesday, 1 November 2022 by Mitch
