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

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Document Management Training Management CAPA Management Audit Management Product Development

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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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Establishing a QMS

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

The Ultimate Guide To Design Controls For Medical Device Companies

Jon Speer
March 17, 2023
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Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols
March 13, 2023
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More
Product Development

Top 40 IMDRF Technical Documents for Medical Devices

Etienne Nichols
March 10, 2023
The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More
Product Development

How to Define User Needs During Design Controls

Etienne Nichols
March 3, 2023
Every medical device begins with the same purpose—to improve the quality of life by meeting the needs of its users. Read More
Establishing a QMS

21 CFR Part 11: A Complete Guide

Etienne Nichols
March 3, 2023
Medical device companies that wish to sell their devices in the US and EU must implement a quality management system that meets the requirements of 21 CFR Part 820 and ISO... Read More
Product Development

Utility Patent vs Design Patent: Choosing the Right One for Your Device

Etienne Nichols
February 28, 2023
If you go through the rigors of designing and developing a medical device, it only makes sense that you’d want to protect your intellectual property. For a physical product,... Read More
Product Development

Does My Device Labeling Comply with 21 CFR 801?

Etienne Nichols
February 28, 2023
Medical device labeling is a core requirement for getting your device onto the market. 21 CFR 801 covers general device labeling and the use of symbols. One thing the... Read More
Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Brittani Smith
February 26, 2023
The pursuit of MedTech Lifecycle Excellence requires that you consider the entire lifecycle of your medical device. This includes systematic monitoring of your device after... Read More
Product Development

7 Essential Steps of a Nonconformance Report

Etienne Nichols
February 24, 2023
Nonconformance is a word no quality manager wants to hear. Read More

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Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.

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