Medical Devices registration/submission in Israel

2018-12-02T11:43:34+00:00December 2nd, 2018|

The process of Medical Device registration and submission in Israel In Israel, the regulatory body that is responsible for Medical Device submission, registration, supervision and control over the manufacture, assembly, [...]

Medical devices Cleaning Validation

2018-01-16T11:20:05+00:00January 16th, 2018|

[vc_row][vc_column][vc_column_text] A contaminated medical device may lead to serious implications and risk to the patient/user. Medical device manufacturers must ensure they have correctly identified all potential risks and contaminants [...]

Cleaning medical devices techniques and validation

2017-09-18T16:34:16+00:00September 18th, 2017|

[vc_row][vc_column][vc_column_text] The purpose of medical device cleaning validation is to assure that the medical device cleaning procedure are consistently controls potential carryover, contaminants, cleaning agents and extraneous material into [...]

Validation- What is it?

2020-08-30T09:10:19+00:00January 27th, 2016|

What is Validation? Validation is documented evidence that demonstrates a process/equipment/system/software/procedure which complies with specifications, criteria and requirements defined in a pre- approved protocol and detailed in: Specifications Definitions [...]

Good Weighing Practice for lab and production balance

2013-06-18T07:20:33+00:00June 18th, 2013|

[vc_row][vc_column][vc_column_text] 1. Introduction Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the Biotechnology and Pharmaceutical areas. Any weighing mistake in case [...]

Corrective And Preventive Actions (CAPA system)

2012-01-22T07:20:22+00:00January 22nd, 2012|

[vc_row][vc_column][vc_column_text]1. Introduction "Non-conformity" investigation is very common term being used in production and product quality improvement areas in the Pharmaceutical and Medical Devices world. It is mandatory and considered [...]

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