RAQA Today

If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then check out this presentation I did with my friends at Greenlight Guru in August.

Etienne Nichols and I sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says about state of the art, what it doesn't say, and how to determine your best path forward.

When submitting a medical device for regulatory approval, it's always better to just dive in, accepting the fact that it's going to take a lot of work and require a lot of patience before you feel the glow of market clearance or approval.

There are just SO MANY things to consider, and remember, and document, and SO MANY regulations to refer to on both sides of the Atlantic.

In this edited version of a Greenlight Guru podcast from earlier this year, I discuss the roadblocks that exist on both sides of the Atlantic with Jon Speer and Etienne Nichols - and share what you can do to make sure you don't end up with an MDR or FDA-induced hangover.

Digital health technologies are exactly new, but they did get a huge boost from COVID and will define how we deliver healthcare in the future.

Digital health includes telemedicine, software functions that allow providers to monitor patients remotely, apps that track medication use and provide user-configured reminders for improved compliance - and more.

In this podcast, we dive into the whys and the hows of regulating digital health while still managing to bring products to market.

The end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next?

Earlier in the year, the FDA laid out their proposed plans for transitioning devices marketed under and EUA or FDA enforcement policy - then went radio silent.

They still haven't released their final guidance, so what's a manufacturer to do?

In this podcast, we'll review the proposed FDA recommendations, suggest the type of feedback industry should provide to the FDA, and discuss actions to take if you are a manufacturer with an active EUA.

In other words, we'll laugh, we'll cry, we'll rail at the insanity that has been the entire EUA process. 😁

So - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub?

If you've answered NO to any of these, then listen in as Michelle explains what you need to do to help your product move smoothly through the submission process and on to premarket approval.

So - you're a hot new startup with a snappy new medical device.

Now what?

Do you have an intended use statement? Do you have the 𝘳𝘪𝘨𝘩𝘵 intended use statement? Do you know for sure that your product qualifies as a medical device? What about your predicate device?

There are a lot of potholes along the road to market clearance or approval, so come along with me as I explain what you need to avoid derailing your go-to-market plans.

Which comes first - design controls or risk management? Both - because the two are inextricably linked. In this podcast, we'll take an in-depth look at both design controls and risk management, the waterfall design process, how/where risk management fits into that process - and vice versa - as well as discuss the ISO and 21 CFR 820 requirements for each stage of the product life cycle.

You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar?

Breathe - and listen in as Michelle walks you through the options.

In this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not do when preparing for your certification, then segue into what you need to consider when building the business case for (or against) pursuing certification.

This one runs a bit longer than 15 minutes because it includes most of the Q+A session, and that has some juicy tidbits you don't want to miss.

Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation of the standards in pursuit of product certification.

In this second installment of a series, I share three real-world examples of what actual clients faced when going through the MDR certification process.

You'll want to listen and learn from their experiences, so you'll be better prepared for your boxing match with your notified body.