WhaleTeq Test Solutionsfor
Medical Device Manufacturers

Medical device manufacturers and medical devices must meet the standards of ISO 13485 and IEC 60601*. As test equipment for medical devices, WhaleTeq products provide customers with the quality and reliability that meet the regulatory requirements.

Measured values may shift after the test equipment is used for a while, so the test equipment needs calibration to maintain its accuracy to carry out precise measurements of products and ensure their quality and stability. Calibration also benefits the test equipment by prolonging its service life with continuous and smooth operations while saving the cost of repeatedly purchasing test equipment from the manufacturer.

At the same time, manufacturers can reduce false passes or false failures in production and maximize productivity by testing products with calibrated equipment. Furthermore, the calibrated equipment may indirectly help avoid the risk of recalling huge amounts of unqualified products resulting in a double workforce, time, money, and even legal disputes.

To comply with medical standards, ensure the quality of medical devices, and reduce the risk of a recall or discards, regular calibration of test equipment is the most convenient and cost-effective option.

*Note: ISO 13485 is an international standard. However, medical device manufacturers are also required to follow the quality control standards of their respective countries, such as QMS of Taiwan, QSR of the U.S., etc.

The manufacturer knows its products best. Like car maintenance and cellphone repair, having experts from the manufacturer conduct calibration is the safest and most quality-assured method.

• Not only check the test results but also adjust the test ability to its optimal condition. Through calibrating the entire measurement range, the stable test ability of the equipment is ensured.
• Check the equipment performance in an all-around way to assess whole functions and adjust correspondingly, not just calibrate the equipment after conducting general tests.
• Determine the pass/fail of test results according to the manufacturer's specifications, so the equipment's state is self-explanatory.
• With the manufacturer's specifications, the calibration can focus on test points that tend to shift and be conducted on multiple points to have detailed coverage.

Step 1. Check the time range

Step 2. Check whether the TAF/ANAB report is required