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
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
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
