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Data collection and management designed for MedTech clinical trials.

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Regulatory Submission

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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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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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

Wade Schroeder
October 30, 2023
Only recently has the medical device industry began designing software-based products that have no direct relationship to hardware devices at all. Read More
Product Development

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

Etienne Nichols
October 25, 2023
It was nothing more than a checklist that saved $175 million and 1,500 lives. Read More
Product Development

IQ, OQ, PQ: A Quick Guide to Process Validation

Jesseca Lyons
October 20, 2023
What is IQ, OQ, PQ? These are the abbreviations we use in the medical device industry for the three steps of process validation: Installation Qualification (IQ), Operational... Read More
Establishing a QMS

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

Laura Maher
October 20, 2023
The global medical device industry is a space where forward thinking meets problem solving, all for the same purpose: to improve the quality of life. However, if you’re going... Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

Etienne Nichols
October 20, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

Etienne Nichols
October 19, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
Establishing a QMS

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

Etienne Nichols
October 17, 2023
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Regulatory Submission

EU MDR - 9 Top Questions Answered (European MDR)

Etienne Nichols
October 17, 2023
What is EU MDR? The European Medical Device Regulation (EU MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and... Read More
Regulatory Submission

MHRA Guidance Document on Clinical Investigations in UK

Stephanie Hinton
October 10, 2023
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency that regulates medical devices and in vitro diagnostics, as well as clinical... Read More

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