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Data collection and management designed for MedTech clinical trials.

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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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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

What is a Class 2 Medical Device in the US?

Tom Rish
February 4, 2023
The goal of anyone involved in medical devices is simple: produce high quality products that improve or save patient lives. 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
Product Development

Process Verification vs Process Validation: What’s the Difference?

Etienne Nichols
February 3, 2023
In a highly regulated industry like MedTech, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing... Read More
Product Development

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

Sara Adams
February 1, 2023
The Periodic Safety Update Report (PSUR) is one of the new postmarket surveillance (PMS) activities required by EU MDR and EU IVDR. These new regulations represent a complete... Read More
Product Development

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

Chris McHale
January 27, 2023
Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news. Read More

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