TECHNOLOGY
product developers , representing companies whose sales make up more than 90 % of the global market for advanced imaging technologies - commended the FDA for taking proactive steps for the regulatory review of software products . MITA hoped the FDA would “ use the pilot to explore the use of external conformity assessment bodies ( e . g . IECEE ) for software development and change controls using relevant existing international standards ”.
Despite concerns voiced about the FDA program by some institutions such as MITA , Dr Miraldo is certain
we ’ ll see a positive impact . “ It will enable a dialogue between regulators and innovators enabling them to direct their strategies to key areas of value , minimising risk and maximising their chances of raising funding ,” she argues , believing payers should also be included in this dialogue to formally incentivise innovation , not only on digital health but in pharma as a whole .
Creators of SaMD ( Software as a Medical Device ) products like the Canada-based Macadamian – a user experience design and software development company focused on the development of healthcare solutions
24 November 2017