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
In an ever-evolving regulatory landscape, cosmetics companies must navigate a complex web of requirements to ensure compliance. The Modernization ofCosmetics Regulation Act of 2022
toxicological risk assessment
Navigating the intricate landscape of FDA medical device approval is a pivotal step for medical device manufacturers aiming to enter the U.S. market. This
The Medical Device Single Audit Program (MDSAP) has become a crucial framework for medical device manufacturers seeking market authorization in Canada and other participating countries.
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
ISO 10993-1 serves as a cornerstone in risk management strategies, providing a framework for assessing the biocompatibility of medical devices by examining chemical substances, extractables, leachables,
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
