There's a new column over at MD+DI in which Grant Ramaley, director of regulatory affairs for Aseptico Inc., discusses the scariness—and costliness—of the third edition of IEC 60601-1:
As an experiment, I recently sent out a comparative quote to investigate my theories. The quote showed that two testing labs I use, Underwriters Laboratories (UL) and Intertek Testing are charging $18,000 to evaluate a low risk device to the older 2nd Edition, and $39,000 to evaluate the same device with the 3rd Edition. This is an extraordinary cost difference. The story doesn’t end there though.
He goes on to say that OSHA does not recognize the third-edition version of the standard, apparently wary of the standard’s reliance on and use of risk management standard ISO 14971. Ramaley also says that testing labs are tacking on costs for collateral standards, significantly raising the price of meeting these standards for medical device OEMs.
Is Ramaley off base? Are these concerns valid? Has your company prepared for these less-talked-about consequences of the third edition of IEC 60601-1? Let us know what you think. —Lawrence Lloyd