Too often, medical device innovators develop their regulatory submission strategy near the end of the product development process, rather than at the start. They often make launch date commitments without considering important regulatory submission issues, such as product efficacy claims and testing to support those claims.
A well-crafted regulatory strategy considers not only FDA and international requirements, but also development and testing costs, development cycles, and profitability concerns. A comprehensive review and appraisal of the current regulatory environment, the relevant guidelines, existing precedents, and any ongoing or anticipated regulatory initiatives regarding your new device, undertaken early in the design process, will help to facilitate a timely, competitive, and successful product clearance or approval.
For more information in regard to crafting an effective regulatory strategy early in the medical device development process, please visit www.mdci.com.
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