Designing a product label, which is compliant with the current regulations of both the U.S. Food and Drug Administration (FDA)
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Get Prepared for Regulatory Inspections!
To maintain business continuity, the healthcare and pharmaceutical industries should comply with the best practice standards and the most current
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FDA’s Computer System Validation Requirements: What you need to know
Computer systems that are in direct contact with a product during its manufacturing, testing or distribution, in an FDA regulated
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FDA’s Action on Antiseptic Wash Products
In September 2016, the US Food and Drug Administration (FDA) announced that it was prohibiting controversial chemicals in products of
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Validation of Reusable Medical Devices –What the FDA Recommends
The growing use of reusable medical devices has led to increased pressure on manufacturers to prove that their reprocessing instructions
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ePharmaceutical Cleanroom that are HVAC and GMP Environmental Control Compliant
Those who are associated with the pharmaceutical industry will know and understand the essence and necessity of a cleanroom facility.
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Inter-relationship between Medical Device Design and Risk Based Control Systems
New realities have presented the medical device manufacturers with favorable circumstances and some challenges. Medical devices are more integrated into
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Design Control Requirements for Medical Devices
The process of developing a new medical device from scratch to introducing it into market is a complex process, particularly
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Essentials of Importing FDA Regulated Products into the US
Medical devices have to meet all the FDA regulations before being imported into the United States. One of the primary
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FDA Draft Guidance for 3D Printed Medical Devices—Impact on the Industry
Recently, the US Food and Drug Administration (FDA) released a new draft guidance for medical device manufacturers working with additive
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