Human
Factors Program Development Let's face it. Medical device
development takes place in a challenging environment laden with legal liabilities
and regulatory demands. Every year manufacturers are compelled to initiate expensive
product recalls because of use-related problems in the field. FDA
estimates that almost half of recalls are attributable to "use errors"
induced by poor design - by the failure of designers to take account of the capabilities
and limitations of device users. As a manufacturer, you
are now required by FDA and other
international regulatory bodies to demonstrate how human factors considerations
were met during your product's development. We can help you develop a human factors
program that meets FDA requirements.
We can help your team understand the who, what, when,
and most importantly, the why of your human factors initiatives. Solves
These Problems  | We
know about FDA’s human factors initiatives and the growing focus by the
Offices of Device Evaluation and Compliance. But what is human factors anyway? |
|
We include usability testing in our product development
process, but are we doing everything we should be to meet FDA requirements for
human factors? | | Our
Quality Department has done a great job of modifying our processes to meet the
human factors requirements of FDA, but how do we get our product teams to buy
in? |
Types of Services
Quality
System Gap Analysis. We’ll review your Quality System to identify
gaps between it and the human factors
requirements of FDA's Quality System Regulation (QSR) and the EU's Medical
Device Directives (MDD). Based on our findings, we’ll generate recommendations
for embedding human factors engineering into your product life-cycle. Human
Factors Plan. We'll develop a plan for human factors activities to support
your next development project. We'll work with you, to create a plan that balances
the skills of your team, the costs and benefits of possible human factors activities,
and the regulatory requirements given your products level of risk.
Benefits
| Identifies
gaps between your quality system and the human factors requirements of FDA's Quality
System Regulation (QSR) and the EU's Medical Device Directives (MDD). |
| Establishes
a plan appropriate for your projects resources, objectives, and the level of risk
for your device. | | Reduces
regulatory risks and legal liabilities. |
Deliverables
Written report or plan. Top^ | 
