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Our Policy's

 
MEDICAL DEVICES AND COMBINATION PRODUCTS

Risk Management

How does Human Factors relate to Medical Devices and Combination Products?

 

Human Factors is a regulatory requirement. Human Factors for Medical Devices and Combination Products specifies a process for Manufacturers and Pharmaceutical companies to analyse, develop and evaluate the usability of their device as it relates to use safety and user satisfaction.

The Usability Engineering Process ensures that manufacturers assess and mitigate risks associated with the use of a product by identifying foreseeable use related risks which could present a hazardous situation leading to harm​. 

The Usability Engineering Process affects both New Product Development and Legacy Devices. The Human Factors Centre can help to determine how much Human Factors evidence is required in pre-market submissions. 

We have expert knowledge in:

  • Airway management

  • Telehealth

  • Drug delivery

  • Radiotherapy and MRI

  • Wearable and Connected Devices (Digital Health)

  • Dialysis

  • Negative Pressure Wound Therapy

  • Surgical devices

  • HCP and Patient Training

  • Chronic Obstructive Pulmonary Disease (COPD)

  • Motor Neurone Disease (MND)

  • Ventilator Assisted Pneumonia

  • Peripheral Arterial Disease (PAD)

  • Rheumatoid Arthritis (RA)

  • Diabetes Type 1

  • Cancer

  • Short Bowel Syndrome

  • Haemophilia A/B