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…
A COMPARATIVE ANALYSIS OF COSMETICS REGULATIONS: ISRAEL VS. GLOBAL
May 2024As we celebrate Israeli Independence Day, it's an opportune moment to explore how Israel's cosmetics regulations stack up against those of other countries…
Medical device manufacturers regarding GDPR
March 2023The European Union (EU) has established medical device regulations to protect the public from potentially unsafe or ineffective products.
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.
Gaining Quality Through ISO 9001 Certification
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.