
Exploring the people, challenges, and opportunities impacting the global #medtech regulatory, reimbursement and policy communities. Likes,RTs,etc ≠ endorsement.
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Joined April 2019
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#ICYMI: One overlooked difference between FDA QMSR and EU MDR could complicate your risk management strategy. The #FDA and EU MDR have different expectations for medical device risk management. See how they compare: bit.ly/4jvzfD9
The next chapter of #medtech is already taking shape. Explore what a new administration could mean for the industry with a FREE Market Pathways feature article: bit.ly/4hR1ZoA
The right #marketaccess strategy can make all the difference in bringing medical technologies to market.
We have the tools to make it easier than ever before.
Get them all here: bit.ly/4hV6FtA
3 areas shaping #medtech: regulation, reimbursement, and market access.
Stay informed with expert insights from the Market Pathways newsletter: bit.ly/4dMJuiL
3 reasons to listen to the Market Pathways Podcast:
• Stay ahead of #medtech policy
• Hear from industry experts
• Gain real-world insights
Listen now: bit.ly/4A3yPcf
1 new EU decision marks a milestone in AI regulation. Implementing Decision (EU) 2026/2274 introduces the first harmonised #AI Act standard focused on quality management systems. Get more access to docs like this from Pathways' Document Depot: bit.ly/4iv111t
With over 4,000 documents available, staying informed about global #medtech regulations has never been more convenient. Explore global medtech regulations and policy updates with Pathways' improved Document Depot: bit.ly/3Uz1K8M
5 free #medtech cheat sheets covering regulatory updates, reimbursement challenges, MDUFA VI, and more. Get key takeaways from our top 2025 articles: bit.ly/4BfIQUV
Market Pathways | MedTech Regulatory & Policy retweeted
The 2025 #NIH Public Access Policy may still leave NIH-funded investigators facing new article processing charges for immediate public access, with an estimated upper-bound annual cost of more than $100 million. ja.ma/4hpzzSm
EU MDR reform is in the spotlight.
3 reasons to listen:
• Understand potential changes
• Hear expert insights
• Stay ahead of #regulatory developments
Listen here: bit.ly/4zmp7kK
Market Pathways | MedTech Regulatory & Policy retweeted
.@MedTechStrat, @Market_Pathways, and the #medtech community are already making plans for Boston.
Come meet some members of our team at Booth #1136 at #MedTechCon:
1 new #FDA final order for infant monitoring #medicaldevices. The agency has codified Class II requirements for OTC pulse rate and oxygen saturation monitors. Get access to more docs like this here: bit.ly/4B9luR0
FDA QMSR and EU MDR take different approaches to residual risk. Learn how manufacturers can align risk management across both markets. Read more: bit.ly/4zPQ3tx #medtech
Source: FDA QMSR; EU MDR 2017/745
What is the biggest #regulatory challenge facing #medtech companies today?
0%FDA Requirements
0%Regulatory Changes
100%Global Approvals
0%Compliance vs. Innovation
1 votes • Final resultsFrom evolving FDA requirements to navigating global regulatory frameworks, medtech companies face an increasingly complex regulatory landscape.
Explore more regulatory insights from Market Pathways: bit.ly/4yhlQ5g
Your free Market Pathways feature article is ready. 📖
Explore what a new administration could mean for the #medtech industry: bit.ly/3TrgCpj
Market Pathways | MedTech Regulatory & Policy retweeted
The European Medicines Agency's Committee for Medicinal Products for Human Use is planning to update a 2018 guideline on good pharmacogenomic practices.
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#ICYMI: There’s plenty happening across the #medtech policy landscape.
Catch up on RAPID, EU Joint Clinical Assessments, MDUFA VI, NTAP updates and more in the latest Market Pathways digital edition: bit.ly/4yxBv13
Stop digging through agency websites for the #medtech docd you need. Pathways' Document Depot lets you search and filter thousands of #regulatory and market access documents from agencies around the world. Learn how to navigate the new Doc Depot: bit.ly/4xZ4Bp7
Market Pathways | MedTech Regulatory & Policy retweeted
Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans tops the to-do list for the FDA Center for Devices and Radiological Health for fiscal year 2027..
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