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Product Development

Overcoming Submission Deficiencies due to Biocompatibility

August 31, 2022
What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance? Read More
Product Development

The Essential Guide to Electronic Case Report Form (eCRF) for Medical Devices

August 30, 2022
In clinical investigations, investigators traditionally use paper Case Report Forms (CRFs) to collect data from participating patients, including patient characteristics and... Read More
Product Development

Understanding FDA’s Special 510(k) Program

August 28, 2022
They say the only constant in this life is change. Whoever first said it may very well have been discussing medical devices. Read More
Product Development

How to Communicate Your Regulatory Strategy to Medical Device Investors

August 26, 2022
In the medical device industry, the regulatory pathway you choose will determine the amount of money and time you need to get your device on the market. Generally speaking,... Read More
Product Development

How to Design an Electronic Case Report Form (eCRF) for Medical Device Studies?

August 25, 2022
In this post, we touch upon a few elements that can help you design a good Electronic Case Report Form (eCRF) when conducting clinical investigations for medical devices. Read More
Product Development

Does Your CAPA Process Need a CAPA?

August 24, 2022
Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why... Read More
Product Development

Everything You Need to Know about Electronic Data Capture (EDC) Systems

August 23, 2022
The purpose of a clinical investigation (or clinical study) is to determine the safety and effectiveness of a novel treatment, such as a medical device. Biostatisticians make... Read More
Product Development

eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use

August 22, 2022
It doesn’t matter how well-engineered or high-quality your medical device is; you still need to make sure people know how to use it. Read More
Product Development

How to Use Queries for Monitoring Medical Device Studies in SMART-TRIAL

August 18, 2022
It can be said that a successful medical device clinical study is defined by its results. To achieve the best possible outcome it is necessary to generate quality data. Read More

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