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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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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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Post-Market Surveillance

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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Post-Market Surveillance

Alternatives to PMCF Clinical Investigations

Jon Bergsteinsson
June 15, 2023
Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance in the EU. PMCF Studies are commonly mentioned throughout the EU MDR... Read More
Product Development

How to Manage Complex Downstream Design Changes to Your Medical Device

Etienne Nichols
June 11, 2023
It would be nice if every device your company ever produced got to remain on the market for decades, completely unchanged. Read More
Post-Market Surveillance

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

Jon Bergsteinsson
May 24, 2023
In the US, post-market clinical studies are not required of every medical device manufacturer. However, FDA does have the authority to order post-market surveillance of any... Read More
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
Post-Market Surveillance

How to use the Greenlight Guru Clinical AE/SAE reporting module

Páll Jóhannesson
May 8, 2023
This blog post highlights the ready-to-use Greenlight Guru Clinical module for Adverse Events (AE) and Serious Adverse Events (SAE). Let’s dive into how the reporting module... 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
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
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

eBOM vs mBOM: What’s the Difference?

Niki Price
March 31, 2023
A bill of materials (BOM) contains all the materials and parts required to build your device, as well as directions for how to use them and where to acquire them. Read More

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