Preparedness and Your Regulatory Strategy Whitepaper

Preparedness and Your Regulatory Strategy Whitepaper

Does your regulatory strategy come into play only at the end of your development process? If so, that’s a big mistake—one that can have disastrous consequences for your product. Building a marketable medical device in the U.S. requires a vast amount of regulatory preparedness from the first day of development. But knowing what to include or how to build your regulatory strategy can be daunting, even for the most established medical device manufacturers.

In this white paper, we outline the most important elements to include in your regulatory strategy— whether you are seeking FDA certification, clearance, or approval—to help ensure you meet the requirements that correspond to your device’s classification.

They include:

• Product code and regulation number determination
• Classification determination
• Identification of applicable standards and guidance documents
• Confirmation or identification of potential predicate devices
• Applicable tests
• Regulatory pathways
• Quality system requirements

Download Preparedness and Your Regulatory Strategy today to ensure your device is well positioned to meet all your regulatory obligations.