𝗙𝗗𝗔'𝘀 𝗡𝗲𝘄 𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗣𝘂𝗹𝘀𝗲 𝗢𝘅𝗶𝗺𝗲𝘁𝗲𝗿𝘀 – 𝗔𝗿𝗲 𝗬𝗼𝘂 𝗥𝗲𝗮𝗱𝘆? The FDA’s proposed updates introduce 𝗲𝘅𝗽𝗮𝗻𝗱𝗲𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘀𝘁𝘂𝗱𝘆 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 and stricter performance evaluation criteria for pulse oximeters. Staying ahead of these changes is crucial for manufacturers aiming to achieve compliance. 𝗚𝗲𝘁 𝘁𝗵𝗲 𝗳𝗮𝗰𝘁𝘀 𝗳𝗮𝘀𝘁! Download 𝗠𝗲𝘁𝗵𝗼𝗱𝗦𝗲𝗻𝘀𝗲’𝘀 𝗙𝗮𝗰𝘁 𝗦𝗵𝗲𝗲𝘁: 𝗞𝗲𝘆 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 for a quick, clear breakdown of the new draft requirements and success criteria. Download now at https://lnkd.in/e-N2ujrm #MedicalDevices #RegulatoryCompliance #PulseOximeters #MethodSense #FDAGuidance
关于我们
MethodSense is a leading global life science consulting firm, providing services and solutions in regulatory strategy, quality assurance, technology and operations. Supported by LuminLogic, MethodSense’s custom-designed regulatory compliant information management software, we help clients maintain compliance throughout the lifecycle of their business, from product design and development through FDA clearance or CE marking and post-market activities. Combining our experience and skills across the medical device sector, MethodSense works at the intersection of engineering and quality to help clients meet compliance requirements, improve their performance and create sustainable value for their stakeholders. With services that include regulatory strategies, software validation, human factors and usability engineering, risk management and quality compliance, MethodSense delivers breakthroughs.
- 网站
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http://methodsense.com
MethodSense, Inc.的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 11-50 人
- 总部
- Morrisville，NC
- 类型
- 私人持股
- 创立
- 2009
- 领域
- FDA Compliance Strategies、Quality System Development、Process & Validation Strategies、Compliance Audits、Software Design Control Evaluations、Risk Remediation、GxP、21 CFR Part 11、ISO、HIPAA和CMM Expertise
地点
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主要
获取路线
One Copley Parkway
Suite 410
US，NC，Morrisville，27560
MethodSense, Inc.员工
动态
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𝗙𝗗𝗔'𝘀 𝗡𝗲𝘄 𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗣𝘂𝗹𝘀𝗲 𝗢𝘅𝗶𝗺𝗲𝘁𝗲𝗿𝘀 – 𝗔𝗿𝗲 𝗬𝗼𝘂 𝗥𝗲𝗮𝗱𝘆? The FDA’s proposed updates introduce 𝗲𝘅𝗽𝗮𝗻𝗱𝗲𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘀𝘁𝘂𝗱𝘆 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 and stricter performance evaluation criteria for pulse oximeters. Staying ahead of these changes is crucial for manufacturers aiming to achieve compliance. 𝗚𝗲𝘁 𝘁𝗵𝗲 𝗳𝗮𝗰𝘁𝘀 𝗳𝗮𝘀𝘁! Download 𝗠𝗲𝘁𝗵𝗼𝗱𝗦𝗲𝗻𝘀𝗲’𝘀 𝗙𝗮𝗰𝘁 𝗦𝗵𝗲𝗲𝘁: 𝗞𝗲𝘆 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 for a quick, clear breakdown of the new draft requirements and success criteria. Download now at https://lnkd.in/e-N2ujrm #MedicalDevices #RegulatoryCompliance #PulseOximeters #MethodSense #FDAGuidance
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𝗡𝗲𝘄 𝗙𝗗𝗔 𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗣𝘂𝗹𝘀𝗲 𝗢𝘅𝗶𝗺𝗲𝘁𝗲𝗿𝘀- 𝗦𝘁𝗮𝘆 𝗔𝗵𝗲𝗮𝗱 𝗼𝗳 𝘁𝗵𝗲 𝗖𝘂𝗿𝘃𝗲 𝘄𝗶𝘁𝗵 𝗠𝗲𝘁𝗵𝗼𝗱𝗦𝗲𝗻𝘀𝗲 𝗮𝗻𝗱 𝗟𝘂𝗺𝗶𝗻𝗟𝗼𝗴𝗶𝗰! The FDA’s new draft guidance on pulse oximeters raises the bar for accuracy, particularly across diverse skin tones. This shift may demand: • Larger, more diverse clinical studies • Rigorous data analysis and reporting • Compliance for both new submissions and previously cleared devices Meeting these expectations will be vital for pulse oximeters and AI-powered cardiovascular devices that rely on them. At MethodSense, we specialize in regulatory strategy, clinical data analysis and submission preparation. Let us help you navigate these changes and ensure your product’s compliance. Contact us today to learn more! https://lnkd.in/eRwarvpB #PulseOximeters #MedicalDevices #FDACompliance #LuminLogic #MethodSense
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We hope you take advantage of this timely and informative presentation from an industry leader.
Navigating the regulatory landscape for AI/ML medical devices can be challenging. Join MethodSense, Inc. CEO Rita King for an exclusive session at the Electronics Life Cycle & Supply Chain Summit, covering optimizing lifecycle management, clinical validation, and FDA submission readiness. What You’ll Learn: • Streamlining product clearance and compliance • Best practices for AI/ML device management • Case studies utilizing tools like LuminLogic Don’t miss this chance to gain insights that can accelerate your path to market readiness! Register for #ELCSCS now: https://lnkd.in/gWFtqgwQ #AIinHealthcare #MedicalDevices #RegulatoryCompliance #HealthTech #FDAApproval #MedTech #DigitalHealth
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Visit MethodSense @ Medica!!
With MethodSense and LuminLogic, you are assured of having the tools and processes to commercialize, sell and continue selling your products without delay. Whether you are a startup, enterprise or growth-oriented medical device company, Contact Us to discover how much time you’ll save and how much more profit you’ll make. Speak with a regulatory expert: https://t.ly/Ut-PK Request a demo of LuminLogic: https://t.ly/W08D4
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With MethodSense and LuminLogic, you are assured of having the tools and processes to commercialize, sell and continue selling your products without delay. Whether you are a startup, enterprise or growth-oriented medical device company, Contact Us to discover how much time you’ll save and how much more profit you’ll make. Speak with a regulatory expert: https://t.ly/Ut-PK Request a demo of LuminLogic: https://t.ly/W08D4
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With MethodSense and LuminLogic, you are assured of having the tools and processes to commercialize, sell and continue selling your products without delay. Whether you are a startup, enterprise or growth-oriented medical device company, Contact Us to discover how much time you’ll save and how much more profit you’ll make. Speak with a regulatory expert: https://t.ly/Ut-PK Request a demo of LuminLogic: https://t.ly/W08D4
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We look forward to this great event!
Meet us at AMDS to learn more! Rita King, CEO will be hosting a workshop @12:05pm CST on Day 1. Click here to schedule a meeting at AMDS: https://t.ly/yEnlT Click here to schedule a demo of LuminLogic today: https://t.ly/1FElY
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Meet us at AMDS to learn more! Rita King, CEO will be hosting a workshop @12:05pm CST on Day 1. Click here to schedule a meeting at AMDS: https://t.ly/yEnlT Click here to schedule a demo of LuminLogic today: https://t.ly/1FElY
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