Designing a product label, which is compliant with the current regulations of both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), is a long and complex process. Pharmaceutical companies are continually managing product-labeling documents such as Summaries of Product Characteristics More..
To maintain business continuity, the healthcare and pharmaceutical industries should comply with the best practice standards and the most current legislation throughout the lifecycle of their product(s). Regulatory inspections aim at conducting an activity to demonstrate that your company is operating in compliance with the More..
Computer systems that are in direct contact with a product during its manufacturing, testing or distribution, in an FDA regulated environment must be validated according to FDA guidelines for computerized systems and documented accordingly. This is required under FDA 21 CFR part 11 – all More..
In September 2016, the US Food and Drug Administration (FDA) announced that it was prohibiting controversial chemicals in products of day-to-day use. After evaluating the issue for more than 35 years, the FDA came up with a list of controversial chemicals, which include triclosan, triclocarban, and 17 More..
The growing use of reusable medical devices has led to increased pressure on manufacturers to prove that their reprocessing instructions for use (IFU) are correct. The FDA in their recommendations define “reprocessing as validated processes used to render a medical device, which has been previously More..
Those who are associated with the pharmaceutical industry will know and understand the essence and necessity of a cleanroom facility. In layman’s terms, a typical urban space can contain as many as 35 million particles per cubic meter, with diameter sizes of 0.5µm or larger. More..
New realities have presented the medical device manufacturers with favorable circumstances and some challenges. Medical devices are more integrated into outpatient, inpatient, and home care. Medical device design and manufacturing have been evolving with technological advances. However, an increase in modern health reforms has increased More..
The process of developing a new medical device from scratch to introducing it into market is a complex process, particularly if software is being used by the manufacturer in developing the device as it presents the possibility of subtle errors. Typically, a device has multiple More..
Medical devices have to meet all the FDA regulations before being imported into the United States. One of the primary steps that foreign medical device manufacturers have to be aware of is that FDA does not identify regulatory sanctions from the foreign countries. The term More..
Recently, the US Food and Drug Administration (FDA) released a new draft guidance for medical device manufacturers working with additive manufacturing, commonly known as 3D printing. The updated draft guidance contains premarket and quality system issues concerning medical devices integrating additive manufacturing (AM), or 3-D More..