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Establishing a QMS

21 CFR Part 11: A Complete Guide

March 3, 2023
Medical device companies that wish to sell their devices in the US and EU must implement a quality management system that meets the requirements of 21 CFR Part 820 and ISO... Read More
Product Development

Research shows eCRFs faster, more reliable than paper CRFs

March 3, 2023
The case report form (CRF) is a staple in clinical studies. These are the forms clinical investigators use to collect patient information related to an ongoing clinical... Read More
Product Development

Utility Patent vs Design Patent: Choosing the Right One for Your Device

February 28, 2023
If you go through the rigors of designing and developing a medical device, it only makes sense that you’d want to protect your intellectual property. For a physical product,... Read More
Product Development

Does My Device Labeling Comply with 21 CFR 801?

February 28, 2023
Medical device labeling is a core requirement for getting your device onto the market. 21 CFR 801 covers general device labeling and the use of symbols. One thing the... Read More
Product Development

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

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

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

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

How to Choose an Electronic Data Capture System to Comply with EU MDR

February 24, 2023
With the changes brought by the Medical Device Regulation (MDR), there is an increasing demand for systems that can support the collection and management of clinical data.... Read More
Product Development

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

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

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