MedTech Regulatory Intelligence Comes of Age
Sean Smith
Founder & Publisher | MedTech, Life Sciences, HealthTech | MDR/IVDR, QA/RA | Leading Voice Program | Worker ??
In this Issue
From the Editor ????| In-Brief?? |?Featured ???| Sections ? | Postscript ??
From the Editor????
Call to Action: In case you missed my updates this week, this may be (The last?) 10x Medical Device Conference if we don’t step up...
?? Featured Upcoming Webinar: Join MLV on Tues, May 14th, for the Definitive MDSAP Program Update with Brian Ludovico and Sebastiano Pane
?? Plus, 10 other super-useful new posts and Martin King's Regulatory Roundup
?? Just Published by MHRA: AI regulatory strategy ensures patient safety and industry innovation into 2030
?? TGA NEWS: Instructions for Use for Medical Devices - Consultation on availability of instructions for use in more flexible formats was shared by Stefano
?? Watch on YouTube: RAQA Deep Dive: Is your medical device actually a drug? With Veronika ValdovaBolletta
In Brief ??
Featured ??
MedTech Regulatory Intelligence Comes of Age
Having dedicated most of my career to regulatory intelligence, this summit represents an important opportunity to engage with key advancements in our field. The World Medical Device Summit (WMDS 2024), presented by the Johner Institut GmbH , is set to unveil the first results of high-priority projects such as regulatory intelligence, regulation as code, and real-time validation of conformity.
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These initiatives are crucial as we strive towards a more streamlined and harmonized global regulatory system.
The goals for this year's summit are ambitious and necessary:
I am particularly looking forward to the discussions on real-time compliance and the harmonization of regulatory systems, which are key to reducing friction and increasing efficiency within our industry.
This summit is a collaborative platform where governments, policymakers, regulatory authorities, academia, healthcare providers, and manufacturers come together to shape the future of medical device regulation.
Stay tuned as I share updates and insights from the summit. Let’s advance our understanding and implementation of regulatory practices to better serve our communities!
??Weekly Regulatory Roundup
By Martin King, April 29, 2024
In This Week's Regulatory Roundup
?? Updates from:
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Postscript ??
Join MLV on Thursday, May 16, for "Mastering PRESUB: FDA Pre-Submission for the MedTech Industry" with expert speaker Michelle Lott, RAC
Thank you for reading.
- Sean
Supporting SaMD Professionals & Companies via Consulting and the MDSW Network | Click below ?? ↓
10 个月Many thanks Sean Smith for sharing Subhi Saadeh great podcast. Cheers!
Great overview and insight! Very appreciative of the mention - thank you, Sean! ??
MHS Europe Sales Manager
10 个月Thanks for the mention Sean! ??
Take control of medical device compliance | Templates & guides | Practical solutions for immediate implementation
10 个月Thanks for the mention Sean Smith ??
????????????????????? ?????????????? & ?????????????? ?????????????????? ???????????? | Open to New Challenges | Medical Device, IVD | Navigating FDA, IVDR, MDR, PRRC | ISO Lead Auditor | ??.????????@??????????????.????
10 个月?????????? ?????? ?? as always Sean for the great, in-depth insight? Next week is looking to be a MedTech Leading Voice regulatory bonanza with: The ???????????????????? ?????????? ?????????????? ???????????? from Brian Ludovico and Sebastiano Pane ?????????????????? ????????????: ?????? ??????-???????????????????? ?????? ?????? ?????????????? ???????????????? with Michelle Lott, RAC The ?????????? ?????????????? ???????????? ???????????? (???????? ????????)?is looking to be a fantastic opportunity to dive ??deeper into regulatory intelligence, and I'm particularly looking forward to hearing the conclusions of the discussions on much-needed real-time compliance and harmonization. Collaboration among stakeholders in the medical device ecosystem is just so important and key for advancing the industry, Hopefully nuturing manufacturers to do more for patient safety. ?????????? ?????? ??again for your commitment?