Countdown to RAPS Convergence 2024

In this Issue

From the Editor ????| In Brief ?? |?Webinars ??? | Featured Post ?? | Sections ? | Postscript ??

From the Editor????

Are you attending RAPS Convergence 2024 in Long Beach, CA, this week? Whether you're a speaker, attendee, or exhibitor, I'd love to meet you to hear about your work.

?? RAPS Pre-Game Interview Reshaping the Future of SaMD Innovation in the EU

Ahead of the upcoming RAPS Convergence, MedTech Leading Voice spoke with James Dewar, the head of the newly established notified body, Scarlet, who will be a panelist at the “Notified Body Forum: State of Play EU MDR and EU IVDR” session.

Watch the video >>

??? This week: HealthTech LATAM

HealthTech LATAM?(Webinar Gratuito en Espa?ol), our first-ever Spanish language webinar with expert speakers?Lina Maria Ramirez Manotas,?Juan M Fernandez, and?Angela Maria Lema-Pérez?discussing the challenges and opportunities of US 510(k) for LATAM device manufacturers.

?? Wednesday, Sept. 18 at 10:00 AM EST. Recording available to all registrants. Register now.

?? PLUS, 10 super-useful new posts and Martin King's Regulatory Roundup!

In Brief ??

• ?? Featured Video: Amanda Maxwell shared a fascinating interview with Tom Melvin and Erik Vollebregt about how MDR and IVDR must change
• Mike B. Wetherington broke down, avoiding common design pitfalls that slow down market entry
• Stefano Bolletta shared the European Commission’s important?FAQs for the Data Act
• Dr. Pallavi Dasgupta posted a useful infographic for understanding the EU MDR’s Standards and Specifications
• IEC 60601-1, 4th Ed. London Updates & The Relationship Of Updated IMDRF N47 & N52 by Leonard (Leo) Eisner
• The FDA’s approved AR/VR medical devices, an upcoming FDA webinar and more were covered in Monday News by Marina Daineko
• 11 useful tips to comply with ISO 14971 were underlined by EU MDR Compliance
• Georg Digel highlighted 13 key points for structuring CAPAs for External Audits
• Tibor Zechmeister overviewed how clinical investigations are regulated under Annex XV of the MDR
• Stephen Jeong explored how the?organization of your regulatory submission documents?can impact the outcome

Upcoming Webinar ???

Medical device manufacturers face starkly different regulatory landscapes when entering the U.S. and European markets.

Understanding these complexities is critical to ensuring compliance and market access as clinical data requirements continue to evolve. Ahead of our upcoming webinar, Clinical Data Requirements: EU vs. US – Critical Differences and Strategies, I sat down with the moderator David Filmore, and expert speakers Maria E. Donawa, M.D., President of Donawa Lifesciences, and Dr. Tom Melvin, Associate Professor of Medical Device Regulatory Affairs at Trinity College Dublin.

510(k) Roundup ?

Highlighting some of this week’s first-time submissions

Here is our second Weekly Roundup! This week, we added a ?? by the companies that were granted their first 510(k).

Congratulations to this week's 50 new 510(k) clearances, including:

• Modular Medical, Inc., for securing 510(k) clearance for the MODD1 Insulin Delivery System, an exciting step forward in accessible diabetes management technology!
• Forest Devices, Inc., for their innovative SignalNED System, a game-changer in prehospital stroke detection that promises faster and more accurate diagnoses.
• Alandra Medical, for the approval of their Mucosal Impedance Measurement System, offering real-time diagnostics to improve gastrointestinal care.

Subscribe for more updates as we continue highlighting the latest 510(k) approvals weekly!

Featured Post ??

How To Efficiently Patch A Medtech Regulatory System ‘Set Up To Fail’

This compelling Medtech Insight video interview by Amanda Maxwell, with Tom Melvin , Associate Professor of Medical Device Regulatory Affairs at Trinity College Dublin, and legal medtech expert Erik Vollebregt from Axon Lawyers, reveal the critical regulatory flaws undermining medical device safety and availability in the EU.

They don’t hold back, offering strong opinions on what needs urgent reform but also practical solutions that could enhance the system’s efficiency without a complete overhaul. Key topics include the role of notified bodies, regulatory over-proceduralization, and the need for EU-wide harmonization.

With Melvin’s clinical and academic expertise and Vollebregt’s leadership in pushing for legislative changes, this discussion is a must-watch for anyone invested in the future of EU medical device regulation.

? Weekly Regulatory Roundup

By Martin King, September 9, 2024

In This Week's Regulatory Roundup

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Postscript ??

Join over 1,300 MedTech professionals who have signed up for our new FREE courses.

1) "EUSTAR" Foundations of Medical Device Regulation (by Johner Institute)

2) MedTech Startup School: "Fundamentals of FDA Clearance and Compliance" (by lean RAQA)

- Sean ??