Every medical device is required to be labeled with an expiration date that is supported by shelf-life data. Accelerated-aging tests are employed to generate this data for design-history files, technical dossiers, and 510 (k) submissions, while concurrently running real-time studies.
For many medical devices that are manufactured from metals and robust plastics, the evaluation time for a product’s shelf life can be significantly shortened by aging the materials at elevated temperatures (often as high as 55oC). Other products, such as biologic materials or products made of thermally sensitive materials, require a more thorough aging study design with environmental chambers relevant to more unique product requirements.
QRA Walk In Chamber
With more than 3000 ft2 of environmental chamber space in 2 Labs, meeting ASTM, ISO, and ICH conditions, QRA International's network of laboratories has the capacity for accelerated aging and real-time shelf-life studies to meet your needs quickly, inexpensively and with full test report submissions.
Our chambers are housed in secured areas, continuously monitored and integrated iand regularly calibrated in accordance to ISO 17025 International Safety Standards.
Website : www.qra.com.sg
Email : mark@qra.com.sg
qrasales@qra.com.sg
QRA INTERNATIONAL PTE LTD.
(TEST LAB FOR BIOMEDICAL AND PHARMACEUTICAL INDUSTRY)
Address : 21 Toh Guan Road
# 04 - 02 Toh Guan Centre
Singapore 608609
Tel : (65) 6795 1486
Choose QRA INTERNATIONAL PTE LTD. to help you :
- 1.Establish product shelf life under both accelerated and real-time conditions.
- 2.Meet regulatory requirements following ISO 11607-1, ASTM F1980, or any custom- testing protocol needed to establish your product’s expiration date.
- 3.Get comprehensive analysis through one provider, including package integrity, sterility, and product functionality testing such as mechanical, electrical, and physicochemical testing.
- 4.Access study progress through our regular test report updates..
- 5.Ensure easy monitoring of multiple long-term studies and a device’s overall protocol plan using a document control system.
- 6.Utilize an International Shipping Specialist (DHL) to ship products anywhere in the world, navigating permitting, importing and customs.
- We have test customers from USA, Middle East, Australia and Asia
- 7. Support protocol writing and method development / validation.
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