HUMAN FACTORS

HUMAN FACTORS IS ESSENTIAL

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Implementing HF processes can optimize the product design and labelling – meaning safer, more effective and easier to use products.

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Regulatory bodies require and expect a robust HF process to be implemented.
The HF process:

Human Factors Process
Human Factors Process
Human Factors Process

WHEN IS HF NEEDED?

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Evidence of acceptable usability is needed to support different medical product filing types.

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Medical Devices
Drug-Device Combination Products
One-Way Labelled Devices By Drug/ Medicinal Product Labeling
Open Label Drug/ Medicinal Products
HF Validation

HF Validation evaluates product usability, safety & efficacy (supports Design Validation). HF Validation is required for Medical Devices and Combination products, and may be requested by Health Authorities to support review of one-way device label claims by drug/ medicinal product labelling.

Labelling readability/ comprehension

Tests that users are able to read and comprehend important and safety critical information from the product labelling. Labelling readability applies to all medical product types.

Drug strength/ Dosage form differentiation

Mix-ups of drug dosage form or strength are a leading cause of medication error and are a key concern of Health Authorities. Specific product differentiation testing may be required to support the review of Combination Products and Drugs/ Medicinal products.