Do you know ISO 13485 for medical standard?

People are familiar with #ISO9001, as many companies pass this certificate, but not that much company got #ISO13485 certified. This is because, compared to normal #ISO9001, it's more stricter to pass ISO13485. Let us figure it out.

ISO13485 is for #medical #standard, has many specific professional provisions according to the characteristics of the medical device industry. Details by below:

About Record Control, it stipulates "The organization shall keep records for a period at least equal to the life of the medical device specified by the organization, but not less than 2 years from the date of release of the product by the organization, or as required by relevant regulations".

About the working environment, it specially requires for product cleaning, pollution prevention, personnel health.

Add Advisory Notice to communication with customer. The title is changed to "Feedback" instead of customer satisfaction in 8.2.1 of #ISO9001, and the contents of providing early warning of quality problems and reviewing experience in the post production stage are added. Because customer satisfaction and customer perception are not suitable for implementation as requirements in laws and regulations.

In addition, there are special requirements for active implantable medical devices and implantable medical devices, that is, "the organization shall record the identity of inspection and test personnel."

About lcd display for medical device, undoubtedly it especially requires #highest #standard, such as it need very high #resolution and #contrast for clearer display performance. Also high #brightness and #IPS technology is excellent performance in bright environment. Brightness is better to be adjustable in case of room of different brightness.

For a good quality medical display, #response time and #lifespan is very important. It's about the lcd display stability for the long run. Hence they need very high requirements for #lcdglass #driverIC #backlight and #polarizer.

Built in 2004, TSD is experienced lcd display manufacturer for medical device, got ISO-13485 passed and serves some world-famous customer that is in the medical industry. We make lcd display, such as color TFT lcd display, monochrome lcd display(TN, STN, FSTN, DFSTN,VA), all kinds of touch panel and custom lcd solutions. We provide high res, high brightness, high contrast, touch panel of high technical level, and use powerful driver IC to make good medical lcd display. Welcome contact.