Will Your IFU Meet Usability Requirements?
Well-written and usable instructions are critical for all users.
Tag Archives: Labeling
Packaging Modalities Must Be Appropriately Validated
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
The Proposal: Marrying the Right Labeling Partner
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?
Who Wants Clean Air and Water?
The QSR does not dictate how to execute a Receiving Inspection program; it only stipulates that purchased materials must be assessed for their suitability to be used in the manufacture of medical devices that are safe and effective in their intended use. It is up to the establishment to define their approach to RI.
Labeling and Packaging Control
Labeling and what constitutes being a label can be confusing for device manufacturers. This week, Devine Guidance explains 21 CFR, Part 820 – Subpart – K, Labeling and Packaging Control, specifically 820.120 (Device Labeling) and 820.130 (Device Packaging). There are three takeaways: The accuracy of device labeling is mission-critical for device manufacturers; product packaging and labeling need to be properly validated, including distribution cycles, storage conditions, and useable shelf life; and famil…
