MDR/IVDR för distributörer & importörer
Unik kurs i MDR/IVDR för dig som har rollen importör eller distributör. Kursinnehåll Efter att regelverken för medicintekniska produkter (Medical Device Regulation, MDR eller In Vitro Diagnostic Regulation, IVDR) infördes 2017 har företag som importerar och/eller distribuerar produkter fått utökade krav att uppfylla. Under denna kurs tittar vi specifikt på kraven för er som är […]
Karolinska
The Galderna
Permobil
Xbrane
Elekta
The Swedish eHealth Agency
AstraZeneca
Regulatory Affairs
Our Regulatory Affairs services Technical documentation Technical documentation is the backbone of your product development and enables future market introduction. We build solutions that are tailored to your intended use, risk class and business objectives and that also free up time and reduce the risk of costly rework. Clinical evaluation Clinical evaluations are not only a requirement in
Quality assurance & QMS
Våra tjänster inom Kvalitetssäkring Kvalitetslednings- system Att skapa ett kvalitetssystem som uppfyller regelverk och standarder är relativt lätt. Att däremot lyckas ta fram ett kvalitetssystem som både är compliant och anpassat utifrån er verksamhet, som blir ett stöd istället för ett hinder, det är allt annat än trivialt. Med rätt kompetens och stöd blir både […]
Validation
Our services in Validation Validation of computerized systems Validating that systems are reliable and comply with regulations and guidelines (such as GAMP) is crucial to meet both regulatory requirements and business needs. We have deep and long-standing expertise in computerized systems validation (CSV), and have been offering training in the field for many years. Validation [...]
Requirements management
Våra tjänster inom Kravhantering Krav- specifikation Rätt krav i kravspecifikationen är grunden för ett framgångsrikt projekt. Vi hjälper dig att samla in, formulera och strukturera krav så att de går att testa, spåra och leva upp till. Samtidigt som vi har koll på underliggande regelverk. Leverantörs-bedömningar Det är viktigt att välja rätt leverantör utifrån krav […]
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 [...]
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 [...]
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 [...]
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 [...].
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 [...]
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 [...].