MDR & IVDR
An introduction to MDR & IVDR especially for those who have the role of importers or distributors The medical device and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). This course provides you with insight and knowledge of, among other things, definitions and the requirements imposed on the economic operators, [...].
MDR
All medical devices that are placed on the European market must be CE marked as proof that the product complies with the applicable legal requirements. During this training you will get an overview of the Medical Device Regulation (MDR), the process of CE marking and insight into the quality management system for medical devices (according to ISO 13485). After the course you will have insight and knowledge of [...].
QA IT
QA has a critical role in assuring the quality of the company's computerized systems in GxP-regulated activities. This course provides an in-depth understanding of the life cycle of a computerized system with a focus on interpretation of regulations and guidelines such as 21 CFR Part 11, EudraLex Volume 4 Annex 11 and Annex 15 and GAMP5. The course gives you the tools to strategically manage [...].
GAMP5
Computerized systems are an essential part of the pharmaceutical and medical device industry, from research and development to clinical trials, manufacturing and distribution. Computerized systems used in the GxP environment must be reliable and adapted to their needs. This course provides an understanding of regulatory requirements and how to effectively quality assure computerized systems. Target audience The course [...]
Software for medical devices
The course starts with an overview of the current rules and regulations, starting with the Medical Device Regulation (MDR) with regard to software. We discuss software documentation in a technical file, including verification and validation, and you get an introduction to risk management and usability. In addition, the course covers the system life cycle of a Medical Device Software (MDSW), with a detailed [...].
GAMP 5
Computerized systems are an important part of the Life Science industry and play a critical role from research and development to clinical trials, manufacturing and distribution. Systems used in GxP-regulated environments must be reliable and carefully customized to meet the specific needs and requirements. Good Automated Manufacturing Practice (GAMP) is a well-established