Tag: Customization
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Tech Innovator Richard Holcomb Joins MethodSense as Chief Growth Officer
Appointment strengthens MethodSense’s expansion strategy and LuminLogic platform leadership as the company accelerates into the AI-driven future of regulatory compliance… Morrisville, NC – July 02, 2025. MethodSense, a regulatory consulting firm and developer of the LuminLogic® compliance management platform, today announced the appointment of Richard Holcomb as its Chief Growth Officer (CGO). A distinguished entrepreneur,…
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MethodSense & LuminLogic 2025 Conference Schedule
Where to Find MethodSense This Fall Join us at key global conferences as we share insights, showcase our LuminLogic® compliance platform, and support innovators bringing life-saving technologies to market. LSI Europe ’25 – The Global Stage for Life-Saving Innovation September 22–26, 2025Barcelona, Spain Visit Conference Website MethodSense will be in Barcelona to meet with European…
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MethodSense Helps Medical Device Companies Meet FDA’s Tougher Draft Guidance for Pulse Oximeters
New FDA Draft Guidance Raises the Bar on Pulse Oximeter Accuracy – MethodSense Leads the Way in Compliance, Clinical Validation, and Regulatory Strategy Morrisville, NC – February 27, 2025 – MethodSense, a leading regulatory and quality consulting firm, is leveraging its deep expertise to guide pulse oximeter manufacturers through the new FDA draft guidance aimed…
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MethodSense Pulse Oximeter White Paper
This white paper explores the key proposed updates in the new FDA draft guidance, their implications for manufacturers, and the ways in which companies can successfully navigate this evolving regulatory landscape.
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MethodSense Pulse Oximeter Fact Sheet
The FDA has introduced updated draft guidance to enhance the accuracy and reliability of pulse oximeters, particularly for diverse skin tones and pediatric populations. This fact sheet outlines key changes, including expanded clinical study requirements, improved accuracy standards, new pediatric testing criteria, updated non-clinical performance testing, and enhanced labeling considerations.
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MethodSense MDR Compliance White Paper
This paper explores how medical device companies can continue to innovate while meeting the stringent requirements of MDR.
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MethodSense FDA Artificial Intelligence Regulatory White Paper
This white paper provides insights into the FDA’s current regulatory approach to AI in medical devices, the challenges companies face, and the strategies necessary to successfully bring these products to market.
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MethodSense FDA Cybersecurity Requirements White Paper
This white paper explores the FDA’s cybersecurity requirements, the challenges manufacturers face in meeting these standards, and how LuminLogic, a quality management platform, streamlines the compliance process. By adopting robust cybersecurity strategies and leveraging tools like LuminLogic, medical device companies can avoid costly delays, protect patients, and bring their products to market faster by doing…
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MethodSense Unveils Enhanced Knowledge Base Service on LuminLogic Platform
FOR IMMEDIATE RELEASE Morrisville, NC – October 1, 2024 – MethodSense, a leading Quality and Regulatory consulting firm for the life sciences and medical device industries, is excited to announce the launch of a comprehensive Knowledge Base service integrated into its LuminLogic platform. This enhanced service is designed to streamline access to essential regulatory, compliance,…
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