Regulatory Strategy – Key to Success

The term strategy is defined as ‘a high level plan to achieve one or more goals under conditions of uncertainty‘. A Regulatory Strategy created by KD&A specifically for your organisation is the best way to ensure success in bringing your medical device from concept to market.  Meeting regulatory requirements can often be an uncertain and complex task for new medical device manufacturers, but with a comprehensive Regulatory Strategy prepared by KD&A, the path to market can be much less daunting.

Designed to provide your organisation with an understanding of specific regulatory requirements for your new medical device in chosen target markets, a Regulatory Strategy Report is your road map to market.

The KD&A Regulatory Strategy Report structure identifies applicable target market regulatory requirements, and maps out the steps to meet requirements in preparation for market launch. Some requirements will feed into product development, quality management system structure and implementation, and testing processes, and therefore must be part of early planning to avoid delays and additional cost. The Report includes:

• Device classification
• Applicable conformity assessment routes in chosen regions
• Identification of applicable harmonised standards
• Expected regulatory fees and time lines
• Recommended road map to market

Let KD&A help you on the way to achieving your market goals. Contact us for a personalised quotation.