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Forced Air Ventilator

forced air ventilator

Case Study: Medical Product Development - Forced Air Ventilator

The Brief: To develop all electronics and documentation for the unit.

ISO13485The Challenge:
As with any medical product critical areas include EN60601, safety requirements, risk analysis and, specifically, accurate control of flow delivery over a very wide range with small reservoir capacity.

MLE were tasked to work with existing documentation to reduce impact on regulatory approvals.

The end result:
A new forced air ventilator with higher spec and better functionality, fully approved.

 

 

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