Cantitate/Preț
Produs

International Medical Device Clinical Investigations: A Practical Approach, Second Edition

Editat de Herman Pieterse, Peter Duijst, M. G. de Jong
en Limba Engleză Hardback – 30 apr 1999
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.
Citește tot Restrânge

Toate formatele și edițiile

Toate formatele și edițiile Preț Express
Paperback (1) 41656 lei  6-8 săpt.
  CRC Press – 23 sep 2019 41656 lei  6-8 săpt.
Hardback (1) 101701 lei  6-8 săpt.
  CRC Press – 30 apr 1999 101701 lei  6-8 săpt.

Preț: 101701 lei

Preț vechi: 124025 lei
-18% Nou

Puncte Express: 1526

Preț estimativ în valută:
19462 20196$ 16267£

Carte tipărită la comandă

Livrare economică 15-29 martie

Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9781574910858
ISBN-10: 157491085X
Pagini: 592
Ilustrații: illustrations
Dimensiuni: 152 x 229 x 38 mm
Greutate: 0.93 kg
Ediția:Revizuită
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States

Public țintă

Academic and Professional Practice & Development

Cuprins

Clinical Regulatory Environment. Design in Clinical Trials. Managing Multi-Dimensional Clinical Projects. Device Classification and Risk Assessment. Clinical Strategy Development. Clinical Trial Project Plan. Quality Assurance for Good Clinical Practices. Protocol Development. The Clinical Investigator's Brochure. Budgeting. The Investigator Contract. Informed Consent. The Design of Case Report Forms. Labeling and Instructions for Use. Ethics Committee Approval. Insurance and Liability. Selection and Training of Clinical Trial Monitors. How to Prepare the Clinic. Monitoring Visits. In-house Monitoring by the Clinic. Data Management. Filing and Archiving. Adverse Event Processing During Clinical Trials. Statistics. Reporting of Data. How to Handle Suspected Fraud.

Notă biografică

Herman Pieterse, Marja G. de Jong , Peter Duijst

Descriere

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.