Medical Device Packaging Requirements

Ensuring your material. Where a control number is required by 820 65 that control number shall be on or shall accompany the device through distribution. Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project.

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Packaging for terminally sterilized medical devices published in 2006 is the principal reference guide for medical device packaging and includes information on testing requirements.

Medical device packaging requirements.

The resilient packaging must also meet rigorous labeling standards which let the fda trace devices in use. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. In short the medical device development is not limited to the devices themselves but. It needs to ensure the integrity of the product from the manufacturer to its final point of use and in some cases the packaging could function in the treatment application.

General device labeling 21 cfr part 801 use of symbols. Package validation testing for medical devices are described in iso 11607. Packaging design is often last on the to do list of medical device manufacturers despite complex regulatory requirements. Astm and ista series distribution testing offer a set of specific test methods for compliance with iso 11607.

Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit lot or batch shall be documented in the dhr. The standard has three main pillars according to ryan erickson a packaging engineer at pcl. Medical device packaging requirements.

The package of a medical device will play a fundamental role in the safe delivery of treatment to patients. The general labeling requirements for medical devices are contained in 21 cfr part 801. Most medical devices are packaged either in a pouch or a tray. Test aims to validate the integrity of the material bubble leak the integrity of the seal resistance of the seal the distribution tests and the aging of the package.

Keystone works closely with kentwood mich based packaging compliance labs pcl which validates sterile medical device packaging according to fda recognized standard iso 11607. These regulations specify the minimum requirements for all devices. Selection criteria for medical device packaging. Industry experts at a recent medical device packaging seminar gave many good reasons why companies should think about it earlier.

If not properly planned for upfront packaging can significantly delay timelines.

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