Long-time readers won’t be surprised that my dear friend, regulatory expert Robert Packard is offering to teach an FDA pre-submission workshop for free.

In fact, the last time we held this workshop – some 3½ years ago – more than 1,500 members registered – which is 500 more “seats” than we have available. So you might wanna click the button below now to register.

I want a seat in Rob’s free workshop!

I guess you could say, “we’re gettin’ the band back together.”

For you Blues Brothers fans, this is one of my all-time favorite scenes in any movie, ever. So many great lines! Spend the four minutes. Thank me later. 🤣

Okay, so, where was I?

Oh, yes, Packard.

Live event: October 25 at noon New York time

The live event will be Thursday, October 25 at noon, New York time. As always, if you can’t make the live event, no prob. We record it and give you the slides afterward. And when you click here to register, I send you to his 2015 presentation, since watched thousands of times.

Coincidentally, Rob is in Amsterdam today, teaching this exact same content – for $600, I might add. So, seriously, come. It’s a gift.

Rob writes, “FDA made a lot of changes to the 510(k) process since our last webinar together, Joe. I can cover some imminent changes and assemble a completely updated presentation, with new tips and tricks I learned from doing dozens of pre-subs since then.

Among the topics:

• Changes to RTA process
• Human Factors Guidance
• Changes to eCopy process
• Small Business Qualification Changes
• Interoperability Guidance
• eSubmitter software status
• Device Modification Guidances
• Quik 510(k) Pilot
• Impact of De Novo & Fee Changes
• Cybersecurity Policies
• UDI Requirements
• New ISO 10993-1:2018 Standard

See you on the 25th?

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When it rains, it pours!

Here’s another freebie for you, courtesy of greenlight.guru, another name you probably recognize by now.

FDA invited us(!) to an FDA live announcement on Thursday, October 18, starting at 11:45 a.m. New York time, for an hour.

FDA will discuss new draft guidance, entitled “Computer Software Assurance for Manufacturing, Operations, and Quality System Software.”

Yes! Sign me up for the FDA announcement!

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Okay, so who needs a new medical device job?

Here are a few opportunities worth highlighting for you today!

Hiring managers and recruiters, you can list your opportunities at https://medgroup.biz/jobs anytime this month for just $39 using code OCTOBER.

Candidates, visit https://medgroup.biz/jobs to create a profile, upload your resume, search by keyword and location (city/state or ZIP), and sign up for job alerts (available at this time only in the US, Canada, UK, and Australia).

Good luck!

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Discussions You May Have Missed

Got a question? This is a free resource for all members. Ask yours at medicaldevicesgroup.net/question/add.

Clément Vallois, Project leader at Fresenius Kabi, has a question about “Finished good article codes”

Saurabh Dubey, Regulatory Affairs & Quality System at Syngene International Limited, asks for “Help with 510(k), GTIN, and GUDID”

Tom Bowen, President at Bowen Medical, wonders if you have to “Sacrifice accuracy of blood pressure cuffs to low cost disposables”

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Thank you for being part of our Medical Devices Group community!

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. If you can’t afford the time to attend the entire 10x for ENGINEERS conference – no problem! Come only for Dr. Black’s talk on Wednesday night. Stay for the reception! Register now.