Medical Devices Labeling Requirements

Labeling Medical Device Process, or large batches of Medical devices, though seemingly simple, may often result in costly recalls for products sold.

Device labeling issues are often the focus of FDA warning letters and 483 notices. They are one of the most important forms of documentation that a medical device company can produce because it will directly impact the way a consumer (both professional and lay) interacts with the device itself. These issues funnel down to the art of human factors management.

e-book

Compliance and Technology: How to meet changing FDA expectations

Product Videos

Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

Video Title
Video Title
Video Title
Video Title

Free Resources

Select all the resources you’re interested in downloading

Data Sheet: MasterControl eMDR Data Sheet: MasterControl eDHR Data Sheet: Manufacturing Quality: Frictionless Quality and Compliance With eDHR
Kit: 11 Free Resources to Boost Your Medical Device FDA Readiness
White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments
Ultimate Guide: The Ultimate Guide to Medical Device Quality Management
Trend Brief: 2024 Medical Device Industry Trends Trend Brief: 2024 Pharmaceutical Industry Trends

Document and Process Management for Labeling Medical Devices

Documentation related to labeling medical device processes can be managed effectively with the MasterControl GxP process management software solutions. With document control and collaboration solutions for example, professionals can collaborate on documentation tasks and can review document information within a web-based system.