How to navigate worldwide regulation in the medical device environment?

MedDEV News (zyk). Coming soon: In September 2017 the new publication "How to navigate worldwide regulation in the medical device environment" will focus on ISO 13485:2016 implementation. This book provides insider knowlede, advise and practical tips concerning regulatory compliance work. It delivers a comprehensive look at medical device (and in vitro diagnostic) management throughout a product´s life cycle. 

Various chapters advise on how to Implement ISO 13485:2016 requirements, how to work in a regulated environment AND how to achieve regulatory compliance for medical devices and medical device companies.

Key Features: The book

• covers compliance with FDA and CE regulations
• provides operational recommendations in regard to ISO 13485:2016 implementation
• focuses regulatory changes
• discusses best practices for Maintaining a compelling QMS
• provides guidance on how to deal with Authotities

Readership:

Freelancers and Employees in the Field of Medical Devices: Decission Makers, Consultants, (Bio)Medical Engineers, Clinicians, Medical Device Developers and Healthcare Professionals

Starting in June, MedDEV news will introduce and summarize the most important topics and chapters.