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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

Customer Discovery for Medical Device Companies

Etienne Nichols
November 2, 2022
What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies. Read More
Product Development

EUA and the Impending Transition

Etienne Nichols
October 26, 2022
There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than... Read More
Product Development

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

Greenlight Guru
October 21, 2022
Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare that millions of patients experience daily. Read More
Product Development

3 Common Misconceptions About Medical Device Labeling

Etienne Nichols
October 21, 2022
When you first start designing and developing a new medical device, you’re investing a lot of time, whether that’s in studying design controls, design inputs and outputs, or... Read More
Product Development

Common QMS Mistakes SaMD Companies Make

Etienne Nichols
October 20, 2022
What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Read More
Product Development

How to Integrate UDI into a Quality System for Your Medical Device

Etienne Nichols
October 16, 2022
Unique Device Identification (UDI) is all about ensuring traceability quality in medical devices. However, integrating it into your quality system will require plenty of... Read More
Product Development

Design Assurance: The Unsung Heroes of R&D

Etienne Nichols
October 13, 2022
What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but... Read More
Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

Jon Speer
October 10, 2022
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Product Development

MDCG 2020-5 Explained: How To Demonstrate Equivalency in the EU

Laura Court
October 9, 2022
MDCG 2020-5 is a guidance document put out by the European Commission (EC) to clarify the process for demonstrating equivalence with another CE marked medical device. Read More

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