Many organizations use a traditional brainstorming approach to identify innovative opportunities for their product, service, or business. Teams undertaking these ambitious efforts can quickly get stuck in the...
Now that your medical device has been approved in Europe and in the US, you’re interested in obtaining approval in other international markets. Will your CE Mark or 510(k) or PMA approval help?
Attribute sampling is based on the confidence level and quality level. For example, to be 95% confident of a minimum 95% yield, the minimum sample size would be 58.4 units, which is rounded up to 59 units....