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CONTACT US

+886-2-2517-6255

CONTACT US

+886-2-2517-6255

SERVICES

-CALIBRATION AND REPAIR

Why does test equipment need to be calibrated?

 

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.

 

Why the in-house calibration is the best choice to calibrate the test equipment?

 

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.

【In-house Calibration and Third-party Calibration Comparison Table】

 

【In-house calibration advantages】

◆ 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.

 

WhaleTeq In-house Calibration benefits you…

 

Reliability

Calibrate to the manufacturer's specifications to ensure performance

◆ Comprehensiveness

Thoroughly inspect the equipment to maintain its performance in the best condition

◆ Traceability

The instruments used for calibration conform with ISO 17025, and TAF/ANAB reports are available to assure the quality and traceable records of WhaleTeq equipment

◆ Efficiency

Complete the calibration in 5 working days to shorten the unavailability for testing

 

WhaleTeq In-house Calibration Services

 

◆ 2 steps to complete the calibration plan that best meets your needs and budget:

Step 1. Check the time range

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

*Note: The 5-day calibration service starts after WhaleTeq receives the equipment. The additional working days for issuing the report and shipping it together with the equipment are as follows:

- TAF report: about 20 working days

- ANAB report: about 10 working days

FAQ

 

1. Does the 5-day calibration service include shipping time?

   → Shipping time is not included. If repair is necessary after inspection, the working days will be extended.

2. How often does WhaleTeq equipment need to be calibrated?

   → It’s recommended to calibrate at least once a year to ensure that the equipment performance is in its best condition. 

3. What if I don't know my equipment has/hasn’t been calibrated before, or if I forget the last calibration time?

  → WhaleTeq can check the calibration records and send an email to remind you of the calibration.

4. Can WhaleTeq provide test data before and after calibration?

  → Yes, customers can learn about their habits on usage according to the test data before and after calibration, and set internal standards of calibration frequency to estimate an accurate budget.

 

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