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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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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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Establishing a QMS

Understanding ISO 14971 Medical Device Risk Management

Etienne Nichols
May 11, 2023
Medical device companies MUST have established risk management processes that comply with ISO 14971. Read More
Product Development

Planning Your Medical Device Global Market Regulatory Strategy

Etienne Nichols
May 5, 2023
A regulatory strategy is more than just picking a pathway to market. It’s an in-depth process by which you choose the best markets and pathways not only for your device, but... Read More
Product Development

3 Things to Love about Internal Audits

Sara Adams
April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

Etienne Nichols
April 21, 2023
One of the biggest factors that determines a medical device company’s success is how effectively they manage quality processes. Read More
Post-Market Surveillance

How to Use Clinical Data in Medical Device Submissions in the EU & US

Jon Bergsteinsson
April 20, 2023
Bringing medical devices to market is still harder than it should be. Obtaining regulatory approval for medical devices is a rigorous process that involves submitting... Read More
Regulatory Submission

4 Reasons to Stop Mixing Your Clinical Data Collection Methods

Páll Jóhannesson
April 17, 2023
They say that variety is the spice of life—but when it comes to blending clinical data collection tools, it’s more like dumping the whole spice rack in the pot. One of the... Read More
Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

Tom Rish
April 14, 2023
It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through... Read More
Post-Market Surveillance

Post-Market Clinical Follow-up Under EU MDR: Guide to PMCF Activities

Etienne Nichols
April 10, 2023
The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipulated by the European Union Medical Device Regulation (EU MDR). Read More
Product Development

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

Etienne Nichols
April 9, 2023
Risk management is a notoriously complex subject—one that many people (including yours truly) have strong feelings about. Read More

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