Is it mandatory for medical device manufacturers to be ISO13485 certified or ISO9001 certified. Is ISO14000 mandatory?

These are voluntary certifications, non-mandatory. But the bidding may be extra points, in the process of talking about foreign customers will be more convincing.

But medical devices exported to the European Union, CE is mandatory certification, exported to the U.S. FDA is mandatory, exported to South Korea KFDA is mandatory, exported to the Japanese Ministry of Health, Labor and Welfare registration is required

The above involves the mandatory as well as non-mandatory certification are our organization can do

Please see my space for more details