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

5 days ago
Joe Hage
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Simply a gift for you today. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download.

Four slides that stood out to me

It was hard to narrow down the four hours from four presentations to four slides. But here goes, from me to you. 😊

Above: FDA Case for Quality Program Manager Francisco Vicenty explained why they're leading the Initiative, saying, "We are in this together: The Agency, the medical device manufacturers, the providers, the hospitals [to] drive the best public health outcomes... We need to change from a compliance mindset to a drive on quality."

The slide shows the present economic impact of today's FDA processes. "People stopped submitting ideas or change activity."

Above: This is a slide Francisco "stole" from Boston Scientific, how they see the difference between an FDA inspection and the new approach, using Capability Maturity Model Integration (CMMI).

Above: A medical device manufacturer proposed this slide. Francisco found it "exceedingly helpful," giving FDA areas where the manufacturer felt their metrics aligned with the Case for Quality Initiative: How they monitor the safety, effectiveness, reliability, and availability of their product.

Above: The main obstacle for medical device manufacturers to justify technology investments? The computer system validation effort: The regulatory and compliance risk associated with implementing that system. Sometimes the cost was 1.5 to 2 times the base system cost, a "huge eye-opening moment for the FDA."

Download the slides, listen to the recordings.

I'll close this section as I began it. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download.

And thanks to Greenlight Guru, the only Quality Management Software designed specifically for the medical device industry, for sponsoring the presentations.


An easier way to use FDA's databases

I'm hosting a webinar next week on how to dramatically simplify extracting data out of FDA databases. You can click the yellow button below to join me.

This is interesting. So, among 64 people who took the survey, this is what they said about their FDA data use. I wonder how you compare.

I hope you'll join us for the live event on December 11 at 2 p.m. Eastern Daylight Time. Click here to register: The slides and replay will be available to all who register.


Leave a penny, take a penny

I had a live chat with Maggie Holland from Sweden this morning. She was following up on her question about transitioning to MDR.

I told her I'd raise it here today, then asked her for a favor. I realize now it's a favor I should ask of every reader.

Please tell your friends about the site and get them registered and involved. This only works if the whole medical device ecosystem comes together and participates in the resource. I don't know the answers all by myself!

It's like the old "leave-a-penny, take-a-penny" containers you'd see at checkouts.

I can now see how many subscribers take pennies. I'm hoping you'll give some pennies back, in the form of expanding our community (for example, share this email with your department), or contributing questions and answers to our community page.

Plus, it makes a lovely holiday gift 🎄 for Joe Hage!

So thank you in advance.


Inquiring Minds Want to Know!

Maggie's question about transitioning to MDR and avoiding clinical equivalence.

Whitney's question about investigational use labels.

Lena's question about the impact of Netflix on our industry.

Robyn's fears about the CRISPR twins!

José's question about MDR2017/745. (Hmm. Two MDR questions! We covered MDR recently.)


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

If you're looking for work, check out the newly posted jobs here!

Make it a great week.

Joe Hage signature

Joe Hage
Medical Devices Group Leader

P.S. I'm excited about our upcoming 10x keynote presentation. Former Proove Biosciences CEO Brian Meshkin will answer the question he gets so often, "What the F**k Happened at Proove Biosciences?!* I really hope you'll come! See the agenda in progress!

2 weeks ago
Whitney Lewis
Quality Assurance Specialist at Blackrock Microsystems

Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?

The devices are not cleared and some may or may not be on a path to be cleared, and the studies being done are not to prove the safety or effectiveness of the device but to aid in research only, but on humans.

Does this labeling requirement only apply when the device itself is under evaluation? or always when using a un-cleared device in human testing?

2 weeks ago
Lena Cordie
President at Qualitas Professional Services, LLC

Netflix - The Bleeding Edge

BBC One Panorama - The Great Implant Scandal

ICIJ - The Implant Files

Are these going to help or hurt the medical device industry?

Are they adding fuel to the fire by rehashing known issues or helping advance patient safety through public awareness?

Do the MDR and the newly announced FDA 510(k) program changes address these concerns?

Is the public getting the full picture?

Would like to hear your thoughts on this - whether you are in the medical device industry or not!

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