Following the implementation of the Medical Device Regulation (MDR) in the EU, several key human factors issues have gained prominence. Our Human Factors (HF) workstream seeks to explore best practice opportunities for Human Factors studies.
Uncertainty surrounding how best to implement current regulatory guidance creates risk in the product design process
There is a lack of clarity around:
- Implementation of regulatory guidance
- Best practice in study design
- information request experiences
- Current guidance can be counterintuitive to good practice (e.g., use of IFU in knowledge testing)
HF studies represent a significant risk in the product design process and can cause significant delay in time-to-market. (e.g., 6-month delays are common). Inconsistency in the agency review process adds risk to planning
Harmonize understanding of regulations and Work with regulators towards aligning practice across the industry
Speed – Faster delivery of innovative solutions for patients
Speed – Reduce delay caused by regulatory feedback
Quality – Gain confidence and reliability in our strategy plans
Speed/$ – Increase ‘right first time’ submission
Quality – Knowledge sharing and aligned good practices
$ – Cost reduction from improved process efficiency
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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