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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Product Development

How the Design Control Process Applies to a 510(k) Premarket Notification

Etienne Nichols
August 19, 2022
At its core, the 510(k) Premarket Notification pathway comes down to assuring regulators that your medical device is safe and effective. Read More
Product Development

How to Use Queries for Monitoring Medical Device Studies in Greenlight Guru Clinical

Jon Bergsteinsson
August 18, 2022
It can be said that a successful medical device clinical study is defined by its results. To achieve the best possible outcome it is necessary to generate quality data. Read More
Product Development

UDI and the Current State of Global Implementation

Nick Tippmann
August 17, 2022
What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and... Read More
Product Development

Why Class 1 Medical Device Companies Need Design Controls (even if it’s not required)

Etienne Nichols
August 12, 2022
I know what you’re thinking. You’ve got a medical device prototype that FDA has categorized as being Class I. Read More
Product Development

The Changing Job Market & How it Affects Careers for MedTech Quality Professionals

Nick Tippmann
August 10, 2022
How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access? Read More
Product Development

How to Calculate Sample Size for Medical Device Studies

Jon Bergsteinsson
August 9, 2022
Sample size has always been one of the first design choices a medical device sponsor has to make for a clinical study. But the calculation of sample size is not the most... Read More
Product Development

What are the Risk Management Documentation Requirements of ISO 14971?

Etienne Nichols
August 7, 2022
Managing risk is one of the most important areas in medical device manufacturing today. Not only does it protect users and patients, it’s also a major requirement of most... Read More
Product Development

3 ISO Compliance Guidelines Every Medical Device Manufacturer Should Follow

Etienne Nichols
August 5, 2022
The word “compliance” can sound like a chore, or some sort of box to check before punching out at 5:00. However, in the medical device industry, compliance is more than a... Read More
Product Development

Digitizing your SaMD Testing

Nick Tippmann
August 3, 2022
What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing? Read More

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