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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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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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Establishing a QMS

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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Product Development

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Tom Rish
February 23, 2023
Your device history record (DHR) is one of the final forms of documentation you’ll need before your product ships. That doesn’t mean it’s an afterthought, however. Read More
Product Development

FDA Human Factors Guidance Draft: What Medical Device Manufacturers Need to Know

Etienne Nichols
February 19, 2023
On December 9, 2022, the FDA issued a new draft guidance,Content of Human Factors Information in Medical Device Marketing Submissions, which provides recommendations for the... Read More
Product Development

5 Processes You Need to Invest In to Bring a Device to Market

Etienne Nichols
February 14, 2023
In our recent 2023 MedTech Industry Benchmark Report, one statistic really caught my eye: Companies are using an average of 9 software tools for medical device development. Read More
Establishing a QMS

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

Etienne Nichols
February 13, 2023
Table of Contents What is 21 CFR Part 820? Read More
Product Development

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

Jesseca Lyons
February 10, 2023
The medical device industry has a lot of acronyms. 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
Product Development

What is a Document Control System?

Etienne Nichols
February 10, 2023
Document control systems are the backbone of quality management systems in the medical device industry. Read More
Product Development

Applying ISO 10993-1 to Medical Device Submission to FDA

Etienne Nichols
February 6, 2023
ISO 10993-1 is the medical device industry’s globally recognized standard for biological evaluation of medical devices and protection of humans is its primary goal. Read More
Product Development

Top Risk Management Tools in the Medical Device Industry

Jon Speer
February 3, 2023
The role of risk management for medical devices is not just a regulatory expectation, it’s a critical part of designing, developing, and manufacturing safe and effective... Read More

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