MDR
Gain an understanding of MDR and its impact on medical device manufacturing. During the training, you will gain insight into the MDR regulatory framework, the CE marking process and the requirements for quality management systems according to ISO 13485. You will have the opportunity to discuss and do exercises, which can help you understand how you can implement the regulations in your business to not only [...]
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. Content The training day [...]
Medtech software
Software work in Medtech, such as Medical Device Software (MDSW), Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), is a highly regulated field. Developing software in this sector therefore requires extensive knowledge of applicable regulations such as MDR and IVDR, as well as guidelines and standards such as MDCG, IEC and ISO. The understanding [...]
GMP
During the training, you will gain insight into the basics of what GMP is and why it exists. Which authorities, requirements and regulations you must comply with. What a quality system is and its components. The importance of good documentation, deviation and change management. Risk and deviation management to understand how you can avoid deviations from GMP regulations. CONTENTS Basic principles [...]
Medtech software
Explore the frontiers of medical software development! During the training you will get an overview of how MDSW, SaMD and SiMD are related and which regulations they are subject to. Theoretical aspects, such as intended purpose, classification and detailed design in software development, are mixed with practical case studies and exercises. We follow a medical device through the entire product development process, and you will have the opportunity to [...]
Software for medical devices
The course begins with an overview of the applicable 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 training covers the system life cycle of a Medical Device Software (MDSW), focusing on [...].
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
Course description All medical devices placed on the European market must be CE marked as proof that the product complies with the applicable legal requirements. During this course 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 [...].
QA IT
In the pharmaceutical industry, where accuracy and reliability are essential, computerized systems play a crucial role throughout the chain from research and development to clinical trials and production. These systems control critical processes in, for example, manufacturing, laboratory analysis and distribution, making their proper functioning essential for the safety and efficiency of the entire production and distribution chain. Quality assurance of computerized [...].
System management
Effective systems management is crucial in regulated industries such as pharmaceuticals, where careful control and oversight of computerized systems is required. These systems, which are critical for everything from research and development to manufacturing and distribution of Pharma, must be managed to ensure consistent performance and compliance with strict regulatory standards. A robust system management helps to [...].
ISO 13485
ISO 13485:2016 is an internationally recognized standard for quality management systems specifically adapted for medical device companies. It is designed to support companies and organizations involved in the design, production, installation and service of medical devices and services. The standard emphasizes the importance of meeting regulatory requirements as well as customer requirements, and is intended to be used by both internal [...]
GMP
All pharmaceutical manufacturers intending to market or manufacture their products in the EU must comply with good manufacturing practice (GMP), regardless of where in the world they are based. GMP defines the minimum standards that a pharmaceutical manufacturer must meet in its production processes. By following GMP, manufacturers can systematically prevent contamination, errors and inconsistencies, which is crucial for patient safety. Compliance [...]
Combination products
Combination products are becoming increasingly common in both the pharmaceutical and medical device sectors, reflecting a trend towards more integrated treatment solutions. These innovative products, which combine Pharma with medical device components, must navigate a particularly complex regulatory environment. The standard for pharmaceutical manufacturing, Good Manufacturing Practice (GMP), offers a foundation, but it does not fully cover the unique requirements of
IVDR
The course is aimed at those who work with in vitro diagnostics and want to learn more about the new IVDR regulation. In May 2022, the old EU directive In Vitro Diagnostic Directive (IVDD) was replaced by the new regulation (2017/746) In Vitro Diagnostic Regulation (IVDR) to which the in vitro diagnostics industry is subject. This course gives you an introduction to the new [...].
MDR
The Medical Device Regulation (MDR) imposes extensive requirements on all medical devices sold and marketed in Europe. For example, the MDR requires medical devices placed on the European market to be CE marked as proof that the product complies with the applicable regulations. The CE marking means, among other things, that the product meets the necessary requirements for safety and [...].
Validation & qualification
Validation and qualification are a fundamental part of the pharmaceutical industry and other sectors of the life sciences industry. These processes ensure that equipment, method, process, premises and systems meet specified requirements and perform reliably for their intended use, meaning that they consistently deliver the expected product and function. Accuracy in these processes is essential [...].
data integrity
In regulated activities such as the pharmaceutical industry, data integrity is fundamental to ensuring that all computerized systems handle data correctly and reliably. This means maintaining and protecting data throughout its lifecycle - from collection to archiving - to guarantee that the information is complete, accurate and accessible to authorized parties. Complying with GxP regulations does not require [...]
MDR & IVDR
Companies producing medical devices, in vitro diagnostics and laboratory medical devices are subject to the Medical Device Regulation (MDR) and/or the In Vitro Diagnostic Regulation (IVDR). Regulations place high demands on all economic operators in the sector, including distributors and importers. It is crucial for these actors to have a thorough understanding of their obligations and responsibilities. With knowledge [...]
Validation & Qualification
During the training, you will gain insight into the basic tools and knowledge for effective validation and qualification through a risk-based approach for both process equipment and computerized systems in Life Science. Through a combination of theory and practical exercises, we explore how you can apply a risk-based approach to both prevent and manage potential nonconformities [...]
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, [...].