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By Jim Kasic, Boulder iQ | Not everyone understands exactly what the terms “intended use” and “indications for use" mean, how they are different, and how they are used. The articulation of each term is critical for the successful development, regulatory approval, and reimbursement of your device. |
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By Andrew Walsh, Thomas Altmann, Ralph Basile, et al. | The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is a guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues. |
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By Leeanne Baker, IMed Consultancy | This is a time of major regulatory changes, and for many, it's been difficult to keep up. This article shares a brief overview and comparison of the regulatory frameworks in the U.S., EU, and U.K., along with key considerations to keep in mind when choosing your first market. |
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| Moisture And Oxygen Risk In The Medical Device Industry | Article | PTI Packaging and Inspection Systems | Learn how oxygen and moisture can be even more aggressive environmental contaminants than bacteria, which steps to take to guarantee product performance and patient safety, and more. |
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