Klinische Prüfung von Medizinprodukten

Clinical investigation of medical devices
Commentary on DIN EN ISO 14155

(Please note: This title is only available in German!)

It is a legal and moral obligation to thoroughly test medical devices before launching them on the market. DIN EN ISO 14155 provides a reliable framework to ensure high standards and, in particular, the protection of the test subjects involved in the test studies. It meets the principles of good clinical practice with specific content. In order to provide users in companies, testing institutes and hospitals with a working aid, DIN Media Verlag has published this commentary. It contains a comprehensive commentary on the standard in its current form. The commentary also takes into account Regulation (EU) 2017/745 MDR, which succeeds the Medical Devices Directive 93/42/EEC.

The fourth, revised edition of the DIN Media commentary addresses the changed legal and normative framework conditions.
 

Practical expertise for the clinical investigation of medical devices

DIN EN ISO 14155 sets out the requirements that must be met in the context of good clinical practice when investigating medical devices. It also forms the basis for mandatory conformity assessments. Due to its scope and high level of specification, an accompanying commentary on the standard just makes sense. “Klinische Prüfung von Medizinprodukten” offers:

• Practical tips
  From theory to practice: Concentrated expert knowledge with specific tips and explanations helps to apply the theoretical requirements of the standard to everyday working life.
   
• Legal aspects
  From the European Medical Device Regulation (MDR) to the German Medical Devices Law Implementation Act and CE labelling: The book explains the interrelationships and the regulations to be complied with.
   
• Clarification of responsibilities
  What tasks and qualifications are there? What role do sponsors play? Which public authorities are involved? These and similar questions are answered in detail.
   
• Planning and carrying out the investigations
  From study design to the preparation of documents, the required authorization and consent, to safety assessments, unplanned interruptions or the trial report, everything you need to know about clinical trials of medical devices can be found here step by step.
   
• The complete original text of DIN EN ISO 14155
  The full text of the standard is included and which means the commentary can be better applied.

In addition, this comprehensive DIN Media volume contains a list of useful links, as well as an index of literature, keywords, images and tables and various working aids (overviews of the databases to be used, the documents to be submitted for clinical trials, etc.).
 

Included in this book:

• Introduction to the standard
• Instructions for this commentary
• Terms and definitions
• Abbreviations
• Clinical investigation of medical devices
• Task managers and responsibilities in clinical trials
• Principles of good clinical practice
• Clinical quality management
• Planning and preparation of clinical trials
• Prerequisites for the start and performance
• Security assessment
• Interruption or end of a clinical trial

This book is for:
Employees of medical device companies, testing facilities and hospitals that are entrusted with the preparation and performance of clinical trials of medical devices, other users of DIN EN ISO 14155