Regulatory bodies require and expecta robust HF process to be implemented.The HF process:
Provides evidence of acceptable usability, use related safety and efficacy to inform regulatory review.
Includes HF Validation as a key component to meeting Design Validation requirements of ISO 13485:2016 (EU) & 21 CFR Part 820.30 (US)
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.
DIFFRENTIATION TESTING
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.
