Answer:
C. Early collaboration
Explanation: Understanding Regulatory Requirements: Early collaboration allows the company to engage with regulatory authorities to understand the specific regulatory requirements and expectations for the new medical device. This ensures that the device is developed with compliance in mind from the beginning.
Reducing Delays: By collaborating early, the company can identify potential regulatory issues or challenges before they become major roadblocks. This helps in avoiding delays in the development and approval process.
Risk Mitigation: Early collaboration enables the company to address any regulatory concerns or potential safety issues upfront, reducing the risk of having to make significant and costly modifications later in the development process.
Efficient Development: By working closely with regulatory authorities from the start, the company can tailor its development and testing processes to align with regulatory expectations, leading to a more efficient and streamlined approval process.
While all options mentioned (documented agreement, frequent communication, and follow-up meetings after submission) are important in regulatory interactions, early collaboration stands out as the most critical because it sets the foundation for a successful and compliant development process for innovative medical devices.