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Product Development

ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over

April 5, 2023
Patient reported outcomes (PRO) are becoming increasingly important to medical device clinical trials. Your regulatory strategy, reimbursement strategy, marketing, and more... Read More
MedTech Lifecycle Excellence

From Closed to Connected: Share Data & Unlock Efficiencies with Greenlight Guru’s Export API

April 4, 2023
  Take a moment to recognize how much meaningful data lives in your Quality Management System (QMS), spanning multiple processes across quality, product development,... Read More
MedTech Lifecycle Excellence

Greenlight Guru Introduces Export API for a Connected Quality Management System

April 4, 2023
MedTech companies can now connect quality system data with other third-party software. Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

April 2, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
Product Development

eBOM vs mBOM: What’s the Difference?

March 31, 2023
A bill of materials (BOM) contains all the materials and parts required to build your device, as well as directions for how to use them and where to acquire them. Read More
Product Development

Medical Device Adverse Event Reporting Regulations: EU vs. US

March 31, 2023
Regulatory authorities in both Europe and the United States require medical device companies to report on some adverse events (AEs) that occur during clinical investigations. Read More
MedTech Lifecycle Excellence

Building Your Design Controls (and Pitfalls to Avoid)

March 29, 2023
What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic... Read More
Product Development

How to Handle Medical Device Adverse Events

March 24, 2023
Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More
Product Development

Electronic Data Capture Systems vs. Paper-based Data Collection

March 24, 2023
In this blog, we’ll be comparing electronic data capture (EDC) systems to paper-based data collection systems. To do so, we’ll be reviewing four independent studies: ... Read More

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