International Medical Device Clinical Investigations: A Practical Approach, Second Edition
by Herman Pieterse /
1999 / English / PDF
13.3 MB Download
The demand for clinical evidence has become an increasingly
important issue in the development of medical devices. This demand
is reflected not only in regulatory requirements but also by
healthcare purchasers as healthcare reforms occur worldwide.
Thirteen renowned experts have drawn on their practical experience
in industry to provide you with this "recipe" book of how to plan,
prepare, implement, and close out a medical device clinical
investigation--regardless of where the trial site may be located.
While many chapters reference the Medical Device Directive, the
principles, philosophies, and methodologies explained are equally
applicable to Active Implantable Medical Devices (AIMD) and
In-vitro Diagnostic (IVD) products.
The demand for clinical evidence has become an increasingly
important issue in the development of medical devices. This demand
is reflected not only in regulatory requirements but also by
healthcare purchasers as healthcare reforms occur worldwide.
Thirteen renowned experts have drawn on their practical experience
in industry to provide you with this "recipe" book of how to plan,
prepare, implement, and close out a medical device clinical
investigation--regardless of where the trial site may be located.
While many chapters reference the Medical Device Directive, the
principles, philosophies, and methodologies explained are equally
applicable to Active Implantable Medical Devices (AIMD) and
In-vitro Diagnostic (IVD) products.
