CS will be exhibiting at the MD&M South show on June 4-6th. Stop by booth #2102 to learn about our latest Medical Material Innovations! #MDMSouth
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Great discussion today on the value of ETR in developing successful strategies for market adoption in the US. Thanks for the opportunity to share my experience!
Experiencing challenges getting your medical product to market? We are hosting a webinar, 'Accelerating Access: A Pathway for U.S. Medical Tech Adoption,' on May 15 with EXCITE International! The panel will be sharing their success stories with Early Technology Review and how to: ✔️ Develop a clear path to market ✔️ Focus your strategy ✔️ Develop strong evidence Join the webinar, sign up! 🔗 https://lnkd.in/gw6Hkhy6
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If you’re a developer, getting a medical device to market, can be challenging. However, there’s an FDA program that can help — Total Product Life Cycle Advisory Program (TAP) Pilot. Launched by the Center for Devices and Radiological Health in 2023, TAP spurs rapid development of safe, effective, high-quality medical devices that are critical to public health. Learn more about our TAP accomplishments in CDRH’s 2023 Annual Report https://lnkd.in/eRQ__dHy
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ICYMI, CDRH's 2023 Annual Report is out, including reference to the LDT proposed rule, expansion of TAP (the Total Product Life Cycle Advisory Program), reflection on the progress of the Digital Health Center of Excellence, and more. A good way to get caught up on FDA's activity with respect to medical devices in 2023 and prepare for what may be down the road in 2024. #FDA #medicaldevices #healthlaw #lifesciences
If you’re a developer, getting a medical device to market, can be challenging. However, there’s an FDA program that can help — Total Product Life Cycle Advisory Program (TAP) Pilot. Launched by the Center for Devices and Radiological Health in 2023, TAP spurs rapid development of safe, effective, high-quality medical devices that are critical to public health. Learn more about our TAP accomplishments in CDRH’s 2023 Annual Report https://lnkd.in/eRQ__dHy
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The "IEC 60601 Guy" | Medical Device Consultant | Product Safety Compliance & Regulatory | Evolving Medical Device Standards
It's great to be at the 𝗜𝗠𝗗𝗥𝗙 𝟮𝟱𝘁𝗵 𝗠𝗲𝗲𝘁𝗶𝗻𝗴 virtually today & tomorrow and 𝗵𝗲𝗮𝗿 𝘀𝗼 𝗺𝘂𝗰𝗵 𝗮𝗯𝗼𝘂𝘁 𝗿𝗲𝗹𝗶𝗮𝗻𝗰𝗲 so we can come together from around the world 🌎 for the core principles of IMDRF that 𝗼𝘂𝗿 𝘄𝗼𝗿𝗸 💼 𝘀𝗵𝗼𝘂𝗹𝗱 𝗯𝗲 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝘁𝗼 𝗮𝗹𝗹. In other words, 𝘄𝗲 𝘀𝗵𝗼𝘂𝗹𝗱𝗻'𝘁 𝗵𝗮𝘃𝗲 𝘁𝗼 𝗱𝘂𝗽𝗹𝗶𝗰𝗮𝘁𝗲 𝗼𝘂𝗿 𝘄𝗼𝗿𝗸 𝗶𝗻 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁 𝗿𝗲𝗴𝗶𝗼𝗻𝘀 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗼𝗿𝗹𝗱 we should submit the same files 🗄️, and use the same standards 📘. Less differences around the world would make everyone's workloads easier for everyone involved and make the important work of vigilance easier to focus on. #IMDRF #FDA #MEDICALDEVICES #IVD #IVDS #COMBINATIONDEVICES #REGULATORYAFFAIRS #QUALITYASSURANCE
This year, the FDA’s Center for Devices and Radiological Health Center Director, Dr. Jeff Shuren is serving as chair of IMDRF. This is the largest attendance in the history of IMDRF — nearly 1,200 people (400 in-person and 800 virtually) from more than 60 countries and 550 public and private sector organizations. Established in October 2011, the International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who aim to accelerate international medical device regulatory harmonization and convergence. Learn more: https://lnkd.in/ekim6Zpy
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Unlock Medical Knowledge! 🩺Access a wealth of medical knowledge and expertise through Karl Storz documents. Stay informed about the latest trends and developments in the field. Learn more: https://buff.ly/4879il5 #HealthcareInsights #MedicalResearch #MedicalUpdates #KarlStorzResources
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Thanks to Deirdre Clune MEP who had strong words today on the need for urgent action on the medical technology regulations! We call for a comprehensive reform to make the regulations work for patients and the health ecosystem. Read our position here: https://bit.ly/49tbpR4
The Medical Device Regulation aimed to establish a robust & transparent framework for medical devices, prioritising safety, health & innovation 💉 But after more than 6 years of implementation, the objectives have still not been met 📉 I am calling for urgent action to address these challenges, so that European patients have timely access to the latest medical devices ⚠️
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the medical device /FDA regulations in Europe and the US really need to review and improve their frameworks in order to properly prioritise safety, health and innovation. Especially in the context of AI and automation in fertility care. @Deirdre Clune MEP hit the nail on the head here! #accesstohealthcare #safeImplementationOfInnovationsinHealthcare #fertility #ivf
The Medical Device Regulation aimed to establish a robust & transparent framework for medical devices, prioritising safety, health & innovation 💉 But after more than 6 years of implementation, the objectives have still not been met 📉 I am calling for urgent action to address these challenges, so that European patients have timely access to the latest medical devices ⚠️
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Is MDR a gigantic mistake, risking the welfare of patients and society both in the short term (no access to necessary medical technology) and in the long run (lack of innovation and fewer new SMEs)? Risk is what may kill you. The risk of not getting treatment is a severe risk with huge implications. The risk for a society that is not constantly inventing, is declining... #MDR #Risk #Innovation
The Medical Device Regulation aimed to establish a robust & transparent framework for medical devices, prioritising safety, health & innovation 💉 But after more than 6 years of implementation, the objectives have still not been met 📉 I am calling for urgent action to address these challenges, so that European patients have timely access to the latest medical devices ⚠️
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We are thrilled reading this review regarding the Sunrise Medical Q50R!
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"Unlock Medical Knowledge! 🩺 Access a wealth of medical knowledge and expertise through Karl Storz documents. Stay informed about the latest trends and developments in the field. Learn more: https://buff.ly/3r3e0zs #MedicalKnowledge #HealthcareInsights #MedicalResearch #MedicalUpdates #KarlStorzResources"
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