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Product Development

How to Handle Medical Device Adverse Events

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

Electronic Data Capture Systems vs. Paper-based Data Collection

March 24, 2023
In this blog, we’ll be comparing electronic data capture (EDC) systems to paper-based data collection systems. To do so, we’ll be reviewing four independent studies: ... Read More
Product Development

Making the BOM & Design Controls Connection

March 19, 2023
Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More
Establishing a QMS

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

March 17, 2023
One of the most critical decisions a MedTech company will make is choosing the right quality management system (QMS) solution. The QMS solution you choose will have a... Read More
Product Development

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

March 16, 2023
For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing research data to produce high-quality... Read More
Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

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

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
Product Development

Complying with Good Clinical Practice in Clinical Data Collection

March 8, 2023
For medical device manufacturers, clinical data is more than a collection of numbers and statistics—it’s a snapshot of the lives of patients you’re trying to help. And while... Read More
Product Development

How to Define User Needs During Design Controls

March 3, 2023
Every medical device begins with the same purpose—to improve the quality of life by meeting the needs of its users. Read More

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