When a company is designing a medical device, a regulatory strategy should be developed. If a regulatory strategy is developed early in the design process, the necessary supporting documentation can be created over the course of continued development. This ensures that the company has what is needed to move forward with regulatory efforts when the design is completed. FDA compliance and/or clearance can thus be achieved with greater ease.
Regulatory strategy encompasses a broad range of activities, some related to regulatory requirements, some related to good business practices, and some involving both regulatory requirements and good business practices. Regulatory Strategy can be subdivided into the following stages: preliminary activities, pre-market, product launch, preparation, and post-market. Services that KBC has provided in each stage are highlighted in the expandable list on this page.