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Product Development

Explaining IVDR Classification for In Vitro Medical Devices

November 19, 2021
The In Vitro Diagnostic Regulation (IVDR), which concerns in vitro diagnostic medical devices in the European Union market, is very different from its predecessor, the In... Read More
Product Development

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

November 17, 2021
Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transformation of the spine industry by making outcomes and technologies... Read More
Product Development

ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide

November 16, 2021
Once a medical device has been designed, developed, and manufactured to specifications, it may feel as though a major bridge has been crossed. Soon, the device will be in the... Read More
Product Development

The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers

November 12, 2021
The internet of things (IoT) is a blanket term used to describe the billions of connected objects and devices around the world that exchange information with other objects,... Read More
Product Development

3 Non-negotiables for Managing Business Risk as a Medical Device Company

November 11, 2021
How seriously do you take risk management? This may seem like an inane question, especially for a professional in the medical device industry. Read More
FDA Regulations

What are the SaMD Requirements from FDA?

November 10, 2021
The market for software as a medical device (SaMD) is growing rapidly as more companies see the possibilities inherent in leveraging their software development expertise for... Read More
Product Development

Failure Mode Effects Analysis: What Is It & When Should You Use It?

November 4, 2021
Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineering. Read More
FDA Regulations

Setting the Record Straight on Usability & Human Factors

November 3, 2021
What is usability? Human factors? Are they one and the same or different in the medical device industry? When do each apply? Whatever you call it, both are very... Read More
Product Development

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

October 31, 2021
In this article you will find a comprehensive list of the most frequently asked questions from participants who attended the Greenlight Guru webinar, Attention ⚠️  ISO... Read More

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