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.
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
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