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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
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
Product Development

5 Tips for Running Effective Internal Quality Audits

March 31, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies. 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
Product Development

Making the BOM & Design Controls Connection

March 19, 2023
Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More
Establishing a QMS

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

March 17, 2023
One of the most critical decisions a MedTech company will make is choosing the right quality management system (QMS) solution. The QMS solution you choose will have a... Read More

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