23
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2
Episodes
Join host, Linda Braddon, owner of SecureBioMed, as she shares her diverse experience, challenges, and tips regarding the complicated yet life-saving journies of the people who develop medical devices.
Episodes
Sunday Sep 24, 2023
Sunday Sep 24, 2023
There are two powerful tools that can make interactive communications with FDA more efficient if your device is eligible. These are: Breakthrough Devices Program (BDP) or Safer Technology Program (STeP)
Listen in as host, Linda Braddon - owner of SecureBioMed, walks you through each option.
Sunday Sep 24, 2023
Sunday Sep 24, 2023
Learn how to use different tools to interact with FDA and get feedback when needed. So two of my favorite tools beyond just a submission is a Q submission and a 513(g). Host Linda Braddon will walk through both options and share the pros and cons of each.
About Host Linda Braddon
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SecureBioMed (SBME) is the ultimate partner for medical device developers looking for comprehensive and reliable solutions. Our knowledgeable team fosters collaboration, working directly alongside our clients to help them meet their needs and achieve their goals, ensuring a smooth and efficient experience throughout the process.
Learn More at //www.securebme.com/