The FDA requires medical device manufacturers to demonstrate the sterility of their products. Whether a device functions in vivo or in vitro, sterility is crucial to ensuring patient safety and maximizing device functionality.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.
For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.
To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Operating with an antiquated QMS raises your risk. Here’s what to consider when modernizing your system.
Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.
The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market.
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.