The Medical Devices Group, and specifically this site, is building the world's most useful website serving the medical device industry.

    3 days ago
    James Davis
    Head of Quality and Regulatory Affairs
    Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
    6 days ago
    Joe Hage
    🔥 Find me at 🔥
    You have a milestone. To achieve it, you need research… so you search. In-house? Crazy talk. Contract Research Organization? Your budget is too small.The University down the road? Now we're talking, you think. They have smart people, cutting-edge equ...
    2 weeks ago
    Joe Hage
    🔥 Find me at 🔥
    Mike Drues is one of the most gifted regulatory people I know. At 10x he said, If you're going to change a medical device in an administrative way, you have two options to handle that. • You notify the FDA (and if you do, how?); or, • You don't notif...
    3 weeks ago
    Joe Hage
    🔥 Find me at 🔥
    If you want an education about human factors, who better than a university professor who is an AAMI chair to teach it? I have the recording, slides, and transcript from MaryBeth Privitera's 10x talk for you today. Human Factors: MB's Main Takeaways U...
      Our annual event, the 10x Medical Device Conference,
      is May 15-16 in San Diego. Join us!

      Get Brochure

      10x Medical Device Conference is the cross-functional event where the entire medical device ecosystem convenes to grow your skills, network, and profit.

      It’s designed to foster strong professional relationships among medical device players eager to learn smarter ways to do things with industry-leading resources.

      For what level? This medical device event is geared equally for senior and junior level professionals in the medical device industry.

      • If you’re senior, you’ll return with ideas the team can use.
      • If junior, you’ll return with specifics lessons, materials, and action items to do your job better.

      Webinars Available for Immediate Download...

      What You Need to Know Before Manufacturing a Wearable Device

      Walt Maclay Voler

      Recorded January 23, 2019
      A plenary session from Walt about the steps you need to take to build a better wearable device and get it cleared through FDA.

      Access the slides and replay now.

      A Much Easier Way to Access and Use FDA Databases

      Rachel Benway Reed Tech Navigator

      Recorded December 11, 2018
      If you routinely access FDA databases, you know it’s a hassle searching multiple sites and matching the data up get a holistic view of the issue. I think I found a solution and I'm inviting you along to discover it with me.

      Access the slides and replay now.

      How to Prepare a Medical Device 510(k) Submission for the FDA

      Rob Packard Medical Device Academy

      Recorded October 25, 2018
      FDA made a lot of changes to the 510(k) process since our last webinar with Rob. Here, he'll cover imminent changes and share new tips and tricks he learned from dozens of pre-submissions.

      Access the slides and replay now.