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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

Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List

Etienne Nichols
May 9, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five... Read More
MedTech Lifecycle Excellence

Entering the Australia & New Zealand Markets: What Medical Device Manufacturers Need to Know

Etienne Nichols
May 8, 2024
Australia and New Zealand are often target countries for MedTech companies looking to expand into a new market. Read More
MedTech Lifecycle Excellence

Medical Device Reporting: The Do's and Don'ts

Etienne Nichols
May 2, 2024
In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). Read More
MedTech Lifecycle Excellence

FDA Issues LDT Final Rule to Regulate Laboratory Developed Tests as IVD Devices

Etienne Nichols
April 30, 2024
FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs). Read More
MedTech Lifecycle Excellence

Building a Partnership with your Regulatory Consultant

Etienne Nichols
April 30, 2024
In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. Read More
MedTech Lifecycle Excellence

Bringing a Self-Funded Medical Device to Market

Etienne Nichols
April 25, 2024
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow... Read More
MedTech Lifecycle Excellence

Managing Risk in Clinical Investigations

Etienne Nichols
April 23, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. Read More
MedTech Lifecycle Excellence

FDA’s PMA Supplements and Amendments: When and How to Use Each

Etienne Nichols
April 19, 2024
The regulatory pathway for getting a Class III medical device to market in the US is known as Premarket Approval (PMA). Given that Class III devices pose the highest risk to... Read More
MedTech Lifecycle Excellence

Speaking the Language of IVD

Etienne Nichols
April 18, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal... Read More

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