Grant Ramaley has long been opposed to the latest edition of IEC 60601-1 because "concerns over credibility of certification to continue to emerge," he says. The standard is intended to be applied to all electronic medical devices traded internationally.
In a new opinion piece, Ramaley claims that 60601-1 3rd edition could be the most expensive and burdensome standard ever developed. And he is equally critical of the notified bodies that are pushing the standard into practice—even though it is not mandatory.
He also notes that regulating bodies, such as OSHA are becoming concerned about the cost considerations, not to mention the ability of testing labs to actually perform the proper inspections based on the third edition.
Ramaley advises firms “not to be misled by product testing labs that have too great of a stake in taking your money, and too little experience in genuine medical device regulatory compliance.”