Activity

  • Khemraj Singh replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 8 years, 6 months ago

    Regulation and standards should be abided by regardless of cost. Calibrations/maintenance are costly, but must be done. Safety inspections – also costly but must be done. Subscribing to these databases are simply a necessity just like all the tasks above. Each company (ISO, FDA, USP, etc.) needs to hire regulation specialists to verify that these standards are up to date. If there is no cost attached to these regulations, corners would be cut. For standards of this magnitude, cutting corners can’t be a possibility.

    80 to 90 percent of startups fail. Maybe making these standards so highly priced contributes to a filtering of only startups and large companies that are guaranteed to prosper.