Stability Studies of Medical Devices

While determining the stability of medical devices following are also considered:

• Storage conditions, e.g. temperature variations, relative humidity, ventilation, air pressure, air-borne contamination, visible light, and other radiation, etc.
• The type of the device and intended use
• The components or materials used for the manufacturing of the device
• Method of manufacture
• Packaging, e.g Products that are packaged in different sizes of packages may each have different stability or shelf life due to the difference in packaging area coming in contact with the product.
• Transportation conditions; e.g., vibration, shock, temperature, humidity, pH, etc.

The following criteria are used to evaluate the stability of medical devices:

• Chemical
• Physical
• Microbiological
• Therapeutic, and
• Toxicological.

Verifying the stability/shelf life of medical device include:

• Storage Plan for medical device
• Sampling plan – that defines the frequency of sampling and test to be performed at each interval
• testing during various phases of stability study
• Evaluating the packaging of the medical device
• Simulation of shipping and handling stress

On-going stability studies of medical devices:

The product can be released in the market based on the data of accelerated Stability Studies of Medical Devices, however, real-time stability studies of medical devices shall be carried out simultaneously.

After a marketing authorization has been granted, the Stability Studies of Medical Devices should be appropriately monitored according to a continuous Programme that will permit the detection of any stability issue (e.g. changes in levels of degradation products)

Maven helps you to design a Stability study plan for your medical device and reduce errors.

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