J
jimbowen
We are a relatively new company in the UK who make contact lenses which are classed as a medical devices. We will in time be looking to supply the US market so are looking towards FDA approval. What I need to know is we are currently trying to validate an R&R procedure for our measuring gauges and the method we have are currently looking at is used by Ford. I have come to understand that this procedure comes from Measurement System Analysis third edition.
Can anyone tell me if this standard would be sufficient and recognised by the FDA?
Can anyone tell me if this standard would be sufficient and recognised by the FDA?