Medical Device
Cosmetics
ISO Standards
IL Ministry of Defense
The changes in risk management standards that every medical equipment manufacturer should be familiar with
October 202414971 ISO standard 2019 edition and 24971 TR standard 2020 edition The risk management process is the central factor in developing a safe…
Navigating (again) the MDR
March 2023The European Union (EU) has established medical device regulations to protect the public from potentially unsafe or ineffective products.
How to Create a Product Safety Update Report (PSUR)
January 2023In about 6 months, the New Medical Device Regulation in Europe will come into force. The regulation is defined as MDR (medical device regulation) and is identified as 2017/745.
Medical device regulation in Israel
January 2023In about 6 months, the New Medical Device Regulation in Europe will come into force. The regulation is defined as MDR (medical device regulation) and is identified as 2017/745.
New Medical Device Regulation - MDR
August 2021In about 6 months, the New Medical Device Regulation in Europe will come into force. The regulation is defined as MDR (medical device regulation) and is identified as 2017/745.
The Guide for the Beginning Medical Device Importer
May 2018You decided to import products that are defined as medical device and from now on you will be called "importer of medical device". Now you must know the Ministry of Health,the customs and the guidelines for import, registration and marketing of medical device. Good luck!
