FDA regulatory requirements for medical devices with control algorithms

被引：0

作者：

Ciarkowski, AA ^{[1
]}

机构：

[1] US FDA, HFZ450, Rockville, MD 20850 USA

来源：

PROCEEDINGS OF THE 2000 AMERICAN CONTROL CONFERENCE, VOLS 1-6 | 2000年

关键词：

D O I：

暂无

中图分类号：

TP [自动化技术、计算机技术];

学科分类号：

0812 ;

摘要：

引用

页码：3497 / 3500

页数：4

共 50 条

[1] Regulatory - FDA destroys seized medical devices
不详
LABORATORY MEDICINE, 2002, 33 (09) : 672 - 672
[2] Regulatory requirements for medical devices in the European Union
Eikelboom, BC
Duijst, P
EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 1996, 12 (01) : 3 - 4
[3] FDA REGULATORY PROCESSES AFFECTING IMPLANTED ELECTRONIC MEDICAL DEVICES
VEALE, JR
JOURNAL OF THE ELECTROCHEMICAL SOCIETY, 1986, 133 (03) : C99 - C99
[4] Regulatory Requirements For Medical Devices And Vascular Ageing: An Overview
Mayer, Christopher Clemens
Francesconi, Martina
Grandi, Caterina
Mozos, Ioana
Tagliaferri, Silvia
Terentes-Printzios, Dimitrios
Testa, Marisa
Pucci, Giacomo
Bianchini, Elisabetta
HEART LUNG AND CIRCULATION, 2021, 30 (11): : 1658 - 1666
[5] Regulatory and legal implications of modifying FDA-approved medical devices
Smith, JJ
JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2000, 11 (01) : 19 - 23
[6] IOM tells FDA to develop new regulatory pathway for medical devices
Thompson, Cheryl A.
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 2011, 68 (18) : 1672 - 1672
[7] Drug delivery devices: Regulatory and quality requirements for medical devices, Part 1
Pharm Technol, 9 (110):
[8] Drug delivery devices: Regulatory and quality requirements for medical devices, Part 2
Pharm Technol, 10 (92):
[9] The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices - Trautman,KA
Bruha, FS
QUALITY PROGRESS, 1997, 30 (08) : 174 - 174
[10] REGULATORY CONTROL OF MEDICAL DEVICES, THE ITALIAN SITUATION
POCCHIARI, F
JOURNAL OF MEDICAL ENGINEERING & TECHNOLOGY, 1986, 10 (01) : A30 - A33

← 1 2 3 4 5 →