Delays? TUV deadline ends a week after August 16th, a delay on a scheduled audit 2 is unheard of. IMO
With many new additions and requirements added to achieve ISO 13485 and CE mark, many medical device company's had to deal with delays. Easy to criticize outside looking in....
RS words of wisdom has been trolling for years, still waiting on that one. Make sure to load the boat at .0016 for the RS and the trips... Is that the plan?