Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project.
Medical device packaging ppt.
Seal strength also allows the medical device manufacturer to confirm the reproducibility of their sealing process and adherence to design specifications.
When sterile medical devices are involved deficient packaging can cause the following problems.
A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes tears and broken seals it also has to withstand sitting on a shelf possibly for years without breaking down.
If not properly planned for upfront packaging can significantly delay timelines.
The importance of packaging to the implementation of a medical device is illustrated in a speech by george brdlik in 1982 that is no less true today.
Most single use sterile medical devices can be opened with a high degree of confidence that the.
Packaging strength is important to show that the package protecting the product is strong enough to contain the product system after distribution or aging.
Poor packaging can cause a host of problems for medical device companies and their customers.
Instrument intended for internal or external use in the diagnosis treatment mitigation or prevention of disease or disorder in human beings or animals as may be specified from time to time by the central government by notification in the official gazette after consultation with the board.
Medical device packaging design is an integral part of delivering your device to market safely and securely with the sterile barrier intact.
The package of a medical device will play a fundamental role in the safe delivery of treatment to patients.
Lockhart s utility function encompasses a diverse array of basic functions such as containment and other added value features for example allowing aseptic presentation in medical device packaging.
An outlook on medical device packaging market growth is presented in this latest research report that reviews industry growth drivers trends regional factors companies as well as provides forecasts for next few years.
Yet this critical process is often given little attention in the overall product development process.
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Packaging is too often neglected as an important characteristic of a medical device.
