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MedTech Lifecycle Excellence

FDA Issues LDT Final Rule to Regulate Laboratory Developed Tests as IVD Devices

June 19, 2024
FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs). Read More
MedTech Lifecycle Excellence

LDT Enforcement Discretion Phaseout: What You Need to Do in the First Year

June 19, 2024
On May 6, 2024, FDA published their Final Rule marking the end of enforcement discretion for lab developed tests (LDTs). Read More
Establishing a QMS

2024 Greenlight Guru True Quality Roadshow: Copenhagen Recap

June 18, 2024
It was a fantastic day in Copenhagen on May 16th! The Greenlight Guru True Quality Roadshow, a sold-out event, brought together a vibrant community of medical device... Read More
MedTech Lifecycle Excellence

Creative Clinical Recruitment

June 13, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment... Read More
Product Development

How to Define Your Design Inputs and Design Outputs

June 12, 2024
In the FDA’s classic waterfall diagram of design controls, design inputs and design outputs are linked by the process of verification. Read More
Product Development

Why FMEA is Not ISO 14971 Risk Management

June 12, 2024
Failure mode effects analysis (FMEA) is a popular tool for identifying the possible failures in the design of a product or process. FMEA is an industry-agnostic engineering... Read More
MedTech Lifecycle Excellence

Getting Hired In MedTech

June 11, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols talks with Mitch Robbins, founder of the Anthony Michael Group, about the evolving landscape of... Read More
Post-Market Surveillance

How to Carry Out PMCF Activities According to EU MDR

June 11, 2024
The Post-Market Clinical Follow-up (PMCF) is a crucial part of the post-market surveillance requirements outlined in EU MDR. The goal of the PMCF is to continuously gather... Read More
MedTech Lifecycle Excellence

Achieving ISO 13485 Certification

June 6, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO... Read More

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