Implementing HF processes can optimize the product design and labelling – meaning safer, more effective and easier to use products.
Regulatory bodies require and expect a robust HF process to be implemented.
The HF process:
Evidence of acceptable usability is needed to support different medical product filing types.
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.
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.
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.