cleaning equipment in the pharmaceutical and medical industries

Tips for choosing the right cleaning agent for production equipment at a medical level in the pharmaceutical and medical industries

Cleaning processes in the Pharma and Medical field   The cleaning process that is developed and used in the pharmaceutical, medical, cosmetic, and food industries must be both effective and proven, while at the same time not endangering the patient or the operator.   Cleaning processes are considered to have an impact on the patient’s…

Medical device registration submission Israel

Medical Devices registration/submission in Israel

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, sterilization, import, and marketing of medical devices is the Medical Device Division of the Israeli Ministry of Health (“AMAR”). The Israeli Medical Device Division deals with granting…

Risk Assessment and Risk Management

Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries

The medical and pharmaceutical industries are involved with new product development and manufacturing (such as medical devices & products, medicines, and combinations thereof). Risk management is a regulatory requirement that medical and pharmaceutical companies are obligated to as part of the risk based approach implementation. Harm to human life, injuries, and side effects, as well…

תהליכי אלקטרופוליש ופסיבציה לנירוסטה

Surface Finish and Biocompatible Materials for Pharmaceutical and Medical Devices

Medical device surface treatment Surface roughness level is a parameter of the surface quality commonly measured as the average deviation of the surface profile from the mean line (Ra). Surface smoothness is one of the parameters used to evaluate medical devices functionality, safety and quality. Smooth surface will be always easier to clean and will…