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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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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

Medical Device Classification Guide - How To Determine Your Device Class

Etienne Nichols
March 7, 2023
What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach to determining how... 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
Post-Market Surveillance

How to Switch from Paper to EDC Systems in Your Next Clinical Study

Jon Bergsteinsson
February 27, 2023
Clinical trials are a crucial aspect of the medical device industry, as they are used to test and validate the safety and efficacy of new treatments and devices. However, 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
Regulatory Submission

How to Choose an Electronic Data Capture System to Comply with EU MDR

Páll Jóhannesson
February 24, 2023
With the changes brought by the Medical Device Regulation (MDR), there is an increasing demand for systems that can support the collection and management of clinical data.... Read More
Product Development

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Tom Rish
February 23, 2023
Your device history record (DHR) is one of the final forms of documentation you’ll need before your product ships. That doesn’t mean it’s an afterthought, however. Read More
Product Development

What is a Class 1 Medical Device?

Etienne Nichols
February 22, 2023
In the US, the governing body tasked with regulating the medical device market is the Food and Drug Administration (FDA). More specifically, the Center for Devices and... Read More

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