Navigating the complex landscape of EU cosmetics regulation is crucial for companies seeking to bring their cosmetic products to the European market. Compliance with these
In today’s highly regulated medical device industry, ensuring compliance with quality standards andregulatory requirements is paramount. Regular internal audits play a crucial role in identifying potential
toxicological risk assessment
The Medical Device Regulation (MDR) 2017/745, a regulation in the European Union (EU), governs medical devices, including Software as a Medical Device (SaMD)[1]. This regulation
Introduction to Medical Device Risk Management Medical device risk management, a critical aspect of product development in the healthcare industry, involves identifying potential hazards associated
Introduction to MDR 2017/745 and ISO 13485 In the medical device industry, quality management and regulatory compliance are of paramount importance. Two significant regulations are
Introduction to MDR 2017/745 The European Union’s Medical Device Regulation (MDR) 2017/745 represents a significant shift in the governing laws for medical devices. It is
