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Join 200,000+ other MedTech professionals outperforming their peers. featured Chris Rush April 12, 2024 Ultimate Guide to Clinical Data Management in MedTech View Post Establishing a QMS FDA Publishes Final Rule on QMSR Etienne Nichols February 2, 2024 View Post Establishing a QMS Guide to Managing Your Medical Device on the Market and Scaling Manufacturing Laura Maher January 3, 2024 View Post Subscribe to Our Blog Join 200,000+ other medical device professionals outperforming their peers. Filter All Blog Posts Browse By Topic Establishing a QMS Clinical Data Collection Ideation & Prototyping Product Development Regulatory Submission Post-Market Surveillance MedTech Lifecycle Excellence Showing Results for MedTech Lifecycle Excellence Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List Etienne Nichols May 9, 2024 In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five... Read More MedTech Lifecycle Excellence Entering the Australia & New Zealand Markets: What Medical Device Manufacturers Need to Know Etienne Nichols May 8, 2024 Australia and New Zealand are often target countries for MedTech companies looking to expand into a new market. Read More MedTech Lifecycle Excellence Medical Device Reporting: The Do’s and Don’ts Etienne Nichols May 2, 2024 In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). Read More MedTech Lifecycle Excellence FDA Issues LDT Final Rule to Regulate Laboratory Developed Tests as IVD Devices Etienne Nichols April 30, 2024 FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs). Read More MedTech Lifecycle Excellence Building a Partnership with your Regulatory Consultant Etienne Nichols April 30, 2024 In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. Read More Clinical Data Collection MDCG 2024-3: What the Latest Guidance on Clinical Investigation Plans (CIP) Tells Us Chris Rush April 30, 2024 A clinical investigation plan (CIP) is the document in which the investigation’s sponsor will lay out the rationale, objectives, design, conduct, record-keeping and analysis... Read More MedTech Lifecycle Excellence Bringing a Self-Funded Medical Device to Market Etienne Nichols April 25, 2024 In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow... Read More Product Development The Risk Management + Design Controls Connection: What Device Makers Need to Know Etienne Nichols April 24, 2024 Medical devices are intended to save and improve quality of life. Read More MedTech Lifecycle Excellence Managing Risk in Clinical Investigations Etienne Nichols April 23, 2024 In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. Read More 1 2 3 4 5 6 7 8 9 1 2 3 4 5 Next Experience the Guru Edge Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success. Academy Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams. Elevate Your Education Community You’re not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence. 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