Medical Device

Home/Medical Device

What is the GMP standard for medical devices?

2020-08-06T17:36:04+00:00December 27th, 2018|

Good manufacturing practice (GMP) requirements in the medical industry are designed to ensure that medical devices and medical equipment (abbreviated as "AMAR" in Hebrew) are manufactured in accordance with [...]

What is medical device/accessory registration?

2020-08-06T17:38:05+00:00December 27th, 2018|

A medical device/accessory may be marketed only after having been approved as a medical device and registered in the Medical Devices Department of the Ministry of Health in accordance [...]

What is fake medical equipment?

2020-08-04T15:22:58+00:00December 27th, 2018|

Fake or counterfeit medical equipment is equipment that has not been approved by the Ministry of Health and is branded by its manufacturer as original equipment that is recognized [...]

What is the medical device development process?

2020-08-06T17:41:30+00:00December 27th, 2018|

The development of medical equipment can be done in two ways: The first is the fast track route, which refers to the process of developing medical equipment that is [...]

What is a quality system in the medical field?

2020-08-04T15:34:30+00:00December 27th, 2018|

A quality system in the medical field is designed to ensure the safety, efficacy and quality of a consumer medical product and has the aim of protecting public and [...]

What is medical validation?

2020-08-04T17:46:46+00:00December 27th, 2018|

Validation is documented proof which provides a high degree of assurance that a system, process, equipment, manufacturing process, and/or medical device software will be properly installed, operated and processed, [...]

צור קשר