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Establishing a QMS

February 26, 2023

Ultimate Guide to Postmarket Surveillance of Medical Devices

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Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

October 4, 2022

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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson

July 17, 2022

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Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols

The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More

Product Development

Top 40 IMDRF Technical Documents for Medical Devices

Etienne Nichols

The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More

MedTech Lifecycle Excellence

Understanding the 'Compliance Manager' Role

Etienne Nichols

What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest. Read More

Product Development

Complying with Good Clinical Practice in Clinical Data Collection

Jon Bergsteinsson

For medical device manufacturers, clinical data is more than a collection of numbers and statistics—it’s a snapshot of the lives of patients you’re trying to help. And while... Read More

Product Development

How to Define User Needs During Design Controls

Etienne Nichols

Every medical device begins with the same purpose—to improve the quality of life by meeting the needs of its users. Read More

Establishing a QMS

21 CFR Part 11: A Complete Guide

Etienne Nichols

Medical device companies that wish to sell their devices in the US and EU must implement a quality management system that meets the requirements of 21 CFR Part 820 and ISO... Read More

Product Development

Research shows eCRFs faster, more reliable than paper CRFs

Jon Bergsteinsson

The case report form (CRF) is a staple in clinical studies. These are the forms clinical investigators use to collect patient information related to an ongoing clinical... Read More

MedTech Lifecycle Excellence

Greenlight Guru Introduces Newly Expanded Global Partner Program

Greenlight Guru

The expanded program will offer more options for both partners and Greenlight Guru customers. Read More

MedTech Lifecycle Excellence

DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

Etienne Nichols

DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the... Read More

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