EN IEC 62366 Medical Device Usability Course

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Use errors caused by inadequate Medical Device Usability have become an increasing cause for concern for Regulators, Medical Device Manufacturers and Healthcare providers alike. Many of the Medical Devices developed without applying a Usability (Human Factors) Engineering process are non-intuitive, difficult to learn and difficult to use. It is the responsibility of the Medical Device manufacturer to reduce all risk as far as possible including usability-related risks. A functioning Usability Engineering process is essential for the Medical Manufacturer in attempting to minimise risk associated with the usability of their devices. This course outlines the requirements for a Usability Process as defined by EN IEC 62366 and the guidance available from the MHRA and the US FDA. The course guides attendees thought the establishment of a Usability Process, how to achieve compliance with EN IEC 62366 and how to use the standard to minimise usability-related risks. The course involves interactive group exercises throughout. The training includes an end-of-course assessment which helps to embed the learning. Attendees who pass the assessment receive a certificate of achievement.

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Contents of EN IEC 62366

The course will examine in detail the requirements for establishment and maintenance of operation of a Usability Engineering Process in accordance with EN IEC 62304.
The course will be tailored from the perspective of a Notified Body rather than a manufacturer.

The requirements of EN IEC 62366 will be covered in detail including activities such as:

MDR Regulatory framework for Usability Engineering
Relationship between EN IEC 62366 & EN ISO 14971
Relationship between EN IEC 62366 & EN IEC 60601-1-6
Usability Engineering Process Overview
Usability Engineering documentation required for new products
Usability Engineering documentation required for legacy products
Expectations for a Use Specification
Identification of potential Use Errors, Hazards and Hazardous Situations
Identification of hazard-related use scenarios and selection for Summative Evaluation
Performance of Formative Evaluation and preparation of a Formative Report
Performance of Summative Evaluation and preparation of a Summative Report
Dealing with User Interfaces of Unknown Provenance (UOUP)

Risk Assessment
This section will look at the relationship between EN IEC 62366 and the Medical Device Risk Management Standard EN ISO 14971. The programme will also cover the implementation of risk assessment to ensure critical use-related risks are identified and reduced as far as possible.

Usability Guidance
The guidance and approach contained in the guidance documents from the MHRA and the US FDA will be discussed and the relationship between these documents and EN IEC 62366 will be explored.

Engineer, Managers, Quality Professionals and other personnel in the Medical Device industry who need to gain a solid foundation in the principles and practices of Usability and Human Factors Engineering for Medical Device Software, Medical Device Hardware and Disposable Medical Devices

Participants in this course will receive the knowledge to enable them to;

Identify the EU regulations regarding Usability Engineering / Human Factors assessment
Identify the steps involved in a Usability Engineering Process
Identify the documents necessary for Usability Engineering for new and legacy products
State the expectations regarding a Use Specification
State expectations regarding;
- Identification of potential Use Errors, Hazards and Hazardous Situations
- Selecting hazard-related use scenarios for Summative Evaluation
- Performance of Formative Evaluation and preparation of a Formative Report
- Performance of Summative Evaluation and preparation of a Summative Report
- Dealing with User Interfaces of Unknown Provenance (UOUP)
State the relationship between EN IEC 62366, EN ISO 14971 and EN ISO 60601-1-6.

John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Snapshot

Course Code

LS040

Duration

1 training day

Delivery Mode

This programme is delivered by or In-Company training

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