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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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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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MedTech Lifecycle Excellence

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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MedTech Lifecycle Excellence

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Etienne Nichols
July 20, 2023
In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine... Read More
MedTech Lifecycle Excellence

Greenlight Guru Continues Strong Growth in Q2 2023 Powered by Product Innovation

Jeff Perkins
July 18, 2023
The company’s recent product launches have helped fuel continued success as large global MedTech companies adopt its solutions. Read More
Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

Etienne Nichols
July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... Read More
Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

Tom Rish
July 14, 2023
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
MedTech Lifecycle Excellence

The Role of dFMEA in Risk Management for Medical Devices

Etienne Nichols
July 12, 2023
How do dFMEA and ISO 14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top... Read More
MedTech Lifecycle Excellence

Understanding the ROI of an eQMS

Etienne Nichols
July 11, 2023
In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Read More
MedTech Lifecycle Excellence

CSA vs. CSV: Modern Validation for Modern MedTech

Etienne Nichols
July 7, 2023
In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in... Read More
Establishing a QMS

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Etienne Nichols
July 6, 2023
You know you need a new QMS solution. You may even have your sights set on an eQMS that you’ve evaluated and believe is the best option for your organization. Read More
Product Development

Identifying and Evaluating Medical Device Importers

Etienne Nichols
July 3, 2023
Expanding into new foreign markets is an exciting chapter for any medical device manufacturer. Read More

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