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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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Featured Capabilities:

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

Medical Device Adverse Event Reporting Regulations: EU vs. US

Páll Jóhannesson
March 31, 2023
Regulatory authorities in both Europe and the United States require medical device companies to report on some adverse events (AEs) that occur during clinical investigations. Read More
Product Development

5 Tips for Running Effective Internal Quality Audits

Etienne Nichols
March 31, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies. Read More
Product Development

How to Handle Medical Device Adverse Events

Etienne Nichols
March 24, 2023
Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More
Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols
March 13, 2023
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More
Product Development

Top 40 IMDRF Technical Documents for Medical Devices

Etienne Nichols
March 10, 2023
The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More
Post-Market Surveillance

How to Switch from Paper to EDC Systems in Your Next Clinical Study

Jon Bergsteinsson
February 27, 2023
Clinical trials are a crucial aspect of the medical device industry, as they are used to test and validate the safety and efficacy of new treatments and devices. However, the Read More
Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Brittani Smith
February 26, 2023
The pursuit of MedTech Lifecycle Excellence requires that you consider the entire lifecycle of your medical device. This includes systematic monitoring of your device after... Read More
Product Development

7 Essential Steps of a Nonconformance Report

Etienne Nichols
February 24, 2023
Nonconformance is a word no quality manager wants to hear. Read More
Product Development

Beginner's Guide to Design Verification & Design Validation for Medical Devices

Jesseca Lyons
February 10, 2023
Design verification and design validation are two essential stages in design controls. It’s easy to confuse the two because they both involve checking an outcome against your... Read More

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