•  11/25/2020 11:08 AM

Aseptic process is carried out usually throughout the production and it also makes sure quality is built into it. It is carefully monitored all along to make sure that quality is built.

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  •  11/25/2020 11:00 AM

Many different ways are used to sterilize Medical Devices like usage of moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods for instance, chlorine dioxide gas, vaporized peracetic acid, and nitrogen

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  •  11/25/2020 10:54 AM

GLP and GMP are at times confused as the same as it pertains to Laboratory testing. It is understandable that both cover Lab Testing still are different. Knowing the difference becomes very important here.

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  •  11/25/2020 05:52 AM

Inspection of ambulatory surgical facilities that perform LASIK procedures is one of the options available to FDA to ensure that physicians and patients have current and accurate information to help them with their decisions about LASIK. These inspections allow FDA to identify reporting problems and provide opportunities to further educate user facilities about MDR reporting obligations.

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  •  11/24/2020 12:46 AM

A recall means that the FDA and/or a manufacturer is aware of a problem with a device that could affect patient safety and health. Most manufacturers voluntarily recall medical devices that are found to have created health risks, but the FDA has the right under law to issue the recall if the company does not do so, or refuses to do so, which is rare. The recall may be related to a correction on a device or total removal of the device from the market.

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  •  11/23/2020 01:04 AM

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. In other words, when the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval

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  •  11/18/2020 08:32 AM

Sterlization plays a very vital and crucial role in Medical Industry. Most commonly used methods are the Heat Method, Filteration , Radiation Sterilization and Chemical Method.

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  •  11/18/2020 08:22 AM

GLP and GMP are at times confused as the same as it pertains to Laboratory testing. It is understandable that both cover Lab Testing still are different. Knowing the difference becomes very important here.

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  •  11/18/2020 01:57 AM

Medical gloves were designed to serve as protective barriers and may still offer some protection even when they are used beyond the manufacturer’s designated shelf life or expiration date.

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  •  11/17/2020 12:14 AM

EUA is a tool used by FDA to authorize the temporary use of products that fulfill urgent medical needs during public health emergencies. These products are authorized for use only in specific circumstances and expire once those conditions end.

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  •  11/16/2020 02:31 AM

An ambulatory surgical facility is a distinct entity whose primary purpose is to furnish same day outpatient surgical services to patients. A facility that offers LASIK as one of its ophthalmic surgical procedures may also provide non-ophthalmic surgical services. Consider all surgical services provided by a facility when determining whether a facility meets the MDR definition of an ambulatory surgical facility and is therefore subject to the user facility obligations under MDR.

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  •  11/13/2020 02:14 AM

The Solidarity Trial is an international clinical trial to help find an effective treatment for COVID-19, launched by WHO and partners. It is hoped that one or more of the treatments under trial will result in improving clinical outcomes in COVID-19 patients and save lives. Other trials are on-going around the world in addition to the Solidarity Trial.

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