CE Marking Process for Medical Device Manufacturers
Navigating CE Marking for Medical Devices: A Comprehensive Guide The journey to obtaining a CE mark for medical devices may initially appear intricate and costly, partly due to misconceptions surrounding the process. However, armed with accurate knowledge and expert guidance, this process can be streamlined for success. This summary serves as your compass, outlining the […]
Ensuring Ethical Conduct and Participant Safety: The Significance of Good Clinical Practice (GCP)
Upholding Ethical Excellence in Clinical Trials: Good Clinical Practice (GCP) and ISO 14155 Good Clinical Practice (GCP) and ISO 14155 play in shaping the landscape of clinical trials. As a medical device professional is it very important to understand these critical practices to advance medical knowledge while adhering to stringent ethical standards and scientific rigor. […]
ISO 14155:2020: Clinical Studies in the Medical Device IndustryIntro
Introduction In the fast-paced and ever-evolving field of medical device development, conducting clinical studies is a crucial step toward bringing innovative products to market. To ensure the highest standards of patient safety, data integrity, and scientific rigor, adherence to internationally recognized guidelines is essential. ISO 14155:2020, the comprehensive global standard for conducting medical device clinical […]
The Importance of ISO 14155 and FDA Regulations for Medical Device Clinical Trials
The Importance of ISO 14155 and FDA Regulations for Medical Device Clinical Trials When it comes to conducting clinical trials for medical devices, adhering to internationally recognized standards is paramount. ISO 14155 is a comprehensive global standard specifically designed to ensure the safety and performance of medical devices throughout clinical investigations. Although not legally binding […]
Entering the European Market: Understanding the Impact of MDR 2017/745 and Compliance Requirements
Historically, it has been perceived that bringing medical products to the European market before the US market is advantageous due to the differences in requirements and processes. The US market entry process, specifically the FDA approval process, has traditionally been more time-consuming compared to the relatively easier process in Europe. Non-compliance issues in Europe were […]
MedTech: A Cornerstone of Modern Healthcare and its Expanding Influence in Europe
Medical technology, or MedTech, stands at the forefront of modern healthcare, offering a diverse array of products, services, and solutions designed to enhance human health. These innovative technologies, ranging from early diagnostic tools to advanced treatment equipment, play a pivotal role in preventing, diagnosing, monitoring, and treating diseases, thereby elevating patient quality of life. In […]
In Vitro Diagnostic (IVD) devices and European CE Marking
The in vitro diagnostic (IVD) devices sold in the European Union require a CE mark to certify that the device complies with the current European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC). The CE mark is a quality certification indicating that the device may be legally commercialized in the European Union. The regulatory framework in Europe is undergoing […]
ISO 20916 for IVD vs. ISO 14155 for Medical Devices
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices Navigating the complex landscape of in-vitro diagnostic (IVD) medical device regulation, ISO 20916 emerges as a beacon of clarity. Established in 2019, this standard marks a paradigm shift in clinical performance studies for IVDs, setting forth comprehensive guidelines tailored to the unique nature of […]
Good study practice for clinical evaluation of in-vitro diagnostic medical devices
In the continually evolving field of medical diagnostics, the introduction of ISO 20916:2019 has marked a significant milestone. Published in May 2019, this International Standard, the first of its kind, meticulously outlines the parameters for clinical performance studies using specimens from human subjects, specifically focusing on in-vitro diagnostic medical devices (IVDs). These devices, instrumental in […]
Career Paths in Clinical Research: Exploring Opportunities in a Growing Field
Navigating Various Clinical Research Career Paths: Exploring Opportunities in Healthcare Advancement Here we share a short guide that unveils the range of career prospects within the dynamic field of clinical research. For those driven by a sincere passion for advancing healthcare through scientific exploration, this summary dives into seven distinct career options, shedding light on […]
