Planning is Key for Regulatory Success

Planning is a recognised and vital step in the development of any medical device…. planning of design, manufacture, customer requirements … the list goes on. However regulatory requirements are often disregarded until submissions for certification is required.

The regulatory framework surrounding medical and IVD devices is complex – insufficient planning from the beginning can result in significant delay and cost for manufacturers and distributors who haven’t factored regulatory requirements into their overall plan.  Whether we like it or not, regulatory compliance is a vital piece of the pie when it comes to success so we must complete sound strategic planning.

KD&A has a solution designed specifically for your company and device(s): A KD&A Regulatory Strategy is your road map to market. We include detailed device classification, available conformity assessment routes in chosen markets, identification of applicable harmonised standards, specific requirements for individual product types, and expected costs and timeframes for development of documentation, QMS, and submissions.

Avoid the stress of unplanned regulatory actions – contact KD&A for a personalised quotation.