ARTICLES

Technical articles focused on the design, development, and commercialization of single-use regulated devices. 

Recent Articles

White paper: FDA Regulated Sterilization Methods

The FDA regulates four critical forms of sterilization: autoclave, dry heat, ethylene oxide, and irradiation. Irradiation includes both gamma ray and electron beam methods. While there are other forms of sterilization, including hydrogen peroxide, high intensity light, and sound waves, these methods are not regulated or approved for use by the FDA at this time. Appropriate, FDA-approved sterilization methods ensure that products are consumable, healthier, and safer for everyone who uses them.

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Demystifying Failure Mode and Effects Analyses (FMEAs) in Medical Device Manufacturing

In Brief

Failure Mode and Effects Analysis (FMEA) is a design review tool used to identify and correct all possible failures in a product, service, design or manufacturing process. This step-by-step approach was first initiated in the 1940s by the United States Army and further developed by NASA in the early 1960s.

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Biocompatibility Testing for Surface Medical Devices: An Overview

In Brief

All medical device companies must subject their products to a volley of FDA-approved tests to establish the safety of their devices. A particular series of these tests measure the biocompatibility of a product where a device/material cannot measure outside of acceptable tolerance ranges in the following "big three" categories: cytotoxicity, sensitivity, and irritation; other tests may be necessary. Furthermore, the types of tests each device must be subjected to vary according to the amount of contact the product has with a patient:

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What Does the Implementation of EU-MDR Mean?

In Brief

The passing of the EU Medical Device Regulations (EU-MDR) is forcing medical device manufacturers to update their clinical testing practices and reporting mechanisms. The body of regulations that preceded the EU-MDR, the Medical Device Directive (MDD) is, in comparison, less than half the size of the EU-MDR, was passed in 1993, and is outdated to such an extent that it does not even contain formal contingencies for the definition and classification of software used in medical devices.

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The Evolution of US Medical Device Regulation

In Brief

Medical devices are regulated according to the same legislation as food and pharmaceuticals, under the general organization of the Food and Drug Administration (FDA). Manufacturers of high-risk devices such as heart valves and intraocular lens transplants have to demonstrate their safety and effectiveness before the devices can enter the market. One drawback is that many companies who develop these devices find the regulatory process to be very conservative, risk-averse, slow and expensive. Other organizations concerned with medical practice such as the National Academy of Medicine argue that the current pre-marketing procedures of the FDA are not comprehensive enough. Many devices are cleared for marketing because they are proven to be "substantially similar" to devices already on the market. 

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