MethodSense looks forward to meeting you at AMDS 2024! Click here to schedule a meeting at AMDS: https://t.ly/yEnlT methodsense.com
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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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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MethodSense and LuminLogic look forward to meeting at AMDS 2024! 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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At MethodSense, we specialize in Regulatory and Quality consulting and have helped many companies successfully navigate the complex regulatory landscape. Our team of experts can provide guidance on regulatory strategy, quality system implementation, and compliance with international standards. Request a meeting: (https://t.ly/Z7Dyj) methodsense.com
When a client’s partner approached the FDA regarding their device's regulatory pathway multiple times, and received a show-stopping designation - their oncology device was misunderstood to be a drug, rather than a device. Learn how MethodSense helped their client to clarify their product, and solidify their relationship with the FDA moving forward: