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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

May 11, 2023
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Product Development

How to use the SMART-TRIAL AE/SAE reporting module

May 8, 2023
This blog post highlights the ready-to-use SMART-TRIAL module for Adverse Events (AE) and Serious Adverse Events (SAE). Let’s dive into how the reporting module benefits... Read More
Product Development

Planning Your Medical Device Global Market Regulatory Strategy

May 5, 2023
A regulatory strategy is more than just picking a pathway to market. It’s an in-depth process by which you choose the best markets and pathways not only for your device, but... Read More
Product Development

3 Things to Love about Internal Audits

April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

April 21, 2023
One of the biggest factors that determines a medical device company’s success is how effectively they manage quality processes. Read More
Product Development

How to Use Clinical Data in Medical Device Submissions in the EU & US

April 20, 2023
Bringing medical devices to market is still harder than it should be. Obtaining regulatory approval for medical devices is a rigorous process that involves submitting... Read More
Product Development

4 Reasons to Stop Mixing Your Clinical Data Collection Methods

April 17, 2023
They say that variety is the spice of life—but when it comes to blending clinical data collection tools, it’s more like dumping the whole spice rack in the pot. One of the... Read More
Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

April 14, 2023
It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through... Read More
Product Development

Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities

April 10, 2023
The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipulated by the European Union Medical Device Regulation (EU MDR). Read More

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