ISO 13485 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES - Fundamentals and Differences from ISO 9001

A reference for medical devices quality management system...

This book has been transcribed from my master of science dissertation entitled "An Application on Differences of ISO 13485 Quality Management System for Medical Devices from ISO 9001 Quality Management System" dated May 2013. The book includes basic information such as objectives, structure, contents, revisions, regulations and requirements, harmonized standards and authorized organizations concerning the standard "ISO 13485 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes which has been designed for medical device manufacturer organizations. Differences of ISO 13485 from ISO 9001 are exhibited. It constitutes a start-up source for implementers become acquainted with ISO 13485.

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(EU) 2017/745 MEDICAL DEVICE REGULATION - Fundamental Changes Compared to Medical Device Directives

The updated legislation that determines the market conditions of medical devices...

(EU) 2017/745 Medical Device Regulation was published in the Official Journal of the European Union in May 2017 and it will be enforced in Turkey in May 2020, at the end of the three-year transition period, simultaneously with the member states of the European Union. This regulation, which combines the requirements for 'medical devices' and 'active implantable medical devices' set by the previous directives separately, sets out the requirements for a medical device to be placed on the market in Europe to obtain the CE marking and details previous legislation introducing sweeping changes. The fact that it has been published at the level of 'Regulation' instead of 'Directive', makes it compulsory for each state subject to this legislation to adopt the requirements to its internal functioning as well as the way they are applied.

(EU) 2017/745 Medical Device Regulation was published in the Official Journal of the European Union in May 2017 and it will be enforced in all the member states of the European Union in May 2020, at the end of the three-year transition period. This regulation, which combines the requirements for 'medical devices' and 'active implantable medical devices' set by the previous directives separately, sets out the requirements for a medical device to be placed on the market in Europe to obtain the CE marking and details previous legislation introducing sweeping changes. The fact that it has been published at the level of 'Regulation' instead of 'Directive', makes it compulsory for each state subject to this legislation to adopt the requirements to its internal functioning as well as the way they are applied.
This book provides brief information on the medical device legislation that will be repealed as of May 2020 and provides a summary of the differences of the (EU) 2017/745 Medical Device Regulation from the legislation it supersedes. It also summarizes the process leading to such a major change and evaluates the extent to which the new law can respond to gaps in previous legislation.
This book is a reference source for institutions and organizations engaged in the medical device manufacture and sale, for persons responsible for regulatory compliance, for students who want to work in this field in the future and for persons who are involved in areas such as audit and consultancy in the CE certification process.