510(k) Tips and Tricks

510(k) Tip - When do you submit a 510(k)?Подробнее

510(k) Tip - Don't worry about classification when you're trying to determine the regulatory pathwayПодробнее

510(k) Tip - When should you submit a 513(g)?Подробнее

510(k) Tip - When should you submit a pre-sub?Подробнее

How to Prepare a Medical Device 510k Submission for FDAПодробнее

Regulatory Compliance through 510(k) Application: Basic Guide for U.S. Medical Device Market EntryПодробнее

510(k) Tip - What's 'special' about a Special 510(k)?Подробнее

510(k) Tip - For SaMD and SiMD, modify your design plan to include software validation documents.Подробнее

510(k) Tip - How do I create a 510(k) summary?Подробнее

510(k) Tip - Make sure you include security controls as software requirements in your SRSПодробнее

510(k) Tip - Schedule 1 on 1 meetings with each subject matter expert (SME) in your company.Подробнее

510(k) Tip - Biocompatibility webinar Feb 29Подробнее

510(k) Tip - Try filling in the FDA eSTAR template while you are obtaining testing quotesПодробнее

510(k) Tip - Divide and conquer.Подробнее

510(k) Tip - how do you create a 510(k) testing plan?Подробнее

510(k) Tip - When is it too early to create a regulatory pathway?Подробнее