Any lag in getting products to market is costly on every front from cash expenditures to loss of market share and the evaporation of the first-to-market competitive edge. Designing medical devices that meet the complex safety certification and regulatory requirements are the most common reasons for delays, especially if these requirements are not known in the early stages of design. With the transition to the 3rd Edition of IEC 60601 globally, the approval process is expected to be more challenging and time consuming than ever. Are you ready for the transition? Do you understand the new requirements?
Fortunately the lag can be shortened substantially with a better understanding before the design phase, to include proper regulatory guidance and the use of a pre-submission evaluation process. These measures can increase product safety and prevent costly errors and delays from accidental omission of vital information.