Before even thinking about interacting with the FDA or your notified body, you must first make sure there is a business case for your device. Many people want to rush to the “fun part” of building and testing their product, but it is very important to put in the necessary work upfront to develop a solid business plan.
Once you have a proper foundation, it's time to make your idea a reality. Learn about the key processes you need in place to make this happen and the relationships and network you must develop to design a product and submit a regulatory submission. Then, discover what lies ahead to make sure there is an adequate supply of your product and that it is actually used in the field.
From early-stage to post-launch considerations, this guide has you covered with the questions to ask yourself and ways to implement and maintain your QMS to be sure you can eliminate stress and uncertainty and increase the chances for success in bringing your medical device to market.