Regulatory Strategy

KD&A will help you understand what you need to do; when you need to do it, and how much will it cost you. The development of a sound regulatory strategy is an essential starting point for medical device and IVD manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market.

Our Regulatory Strategy Report identifies applicable target market regulatory requirements, and maps out the steps to meet requirements in preparation for market launch. Some requirements will feed into development and testing processes, and therefore must be part of early planning to avoid delays and additional cost.

We work with you to develop a plan that helps to get your medical device or IVD to market quickly and efficiently

The KD&A Regulatory Strategy 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

Indicative Fee: between AUD$5,500 and AUD$7,150 plus GST. This is dependant on device type and complexity, and the number of target markets included.

Contact us if you require a custom quote.

Have a few questions? Visit our Frequently Asked Questions page.