Wolfgang Ecker

With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges!

Fit for the new EU-Regulations: Your complete seminar for projects, study and jobob

Medical Devices and IVDs

Wolfgang Müller

Rainer Dömer

Despite its importance, the role of HdS is most often underestimated and the topic is not well represented in literature and education. To address this, Hardware-dependent Software brings together experts from different HdS areas. By providing a comprehensive overview of general HdS principles, tools, and applications, this book provides adequate insight into the current technology and upcoming developments in the domain of HdS. The reader will find an interesting text book with self-contained introductions to the principles of Real-Time Operating Systems (RTOS), the emerging BIOS successor UEFI, and the Hardware Abstraction Layer (HAL). Other chapters cover industrial applications, verification, and tool environments. Tool introductions cover the application of tools in the ASIP software tool chain (i.e. Tensilica) and the generation of drivers and OS components from C-based languages. Applications focus on telecommunication and automotive systems.

Principles and Practice

Hardware-dependent Software

Gerold Labek

Tarquin Mittermayr

Brigitte Raffeiner

Michael Ring

Bernhard Schwartz

The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

Wolfgang Ecker

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