SCOPUS 정보 검색 플랫폼

Drug Safety

Volumn 24, Issue 12, 2001, Pages 869-872

Post-marketing surveillance and vigilance for medical devices: The European approach

(1) Randall, H a

a Medical Devices Agency (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EUROPE; HEALTH CARE POLICY; MEDICAL INSTRUMENTATION; MONITORING; PERFORMANCE; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; UNITED KINGDOM;

EID: 0035174918 PISSN: 01145916 EISSN: None Source Type: Journal
DOI: 10.2165/00002018-200124120-00001 Document Type: Review

Times cited : (12)

References (13)

1
- 0006618806
- Council Directive: 90/285/EEC concerning Active Implantable Medical Devices, OJ L189; 1990 Jun 10

2
- 0006596886
- Council Directive: 93/42/EEC concerning Medical Devices, OJ L169; Volume 36; 1993 Jul 12

3
- 0006529589
- Council Directive: 98/79/EC concerning In Vitro Diagnostic Medical Devices OJ L331/1; 1998 Oct 27

4
- 0006536198
- Mar
- (1998) The European Commission guidelines on a medical devices vigilance system, (MEDDEV 2.12/1). 3 rev.

5
- 0003421595
- London: Medical Devices Agency; Sep. MDA Publication
- (1998) Guidance on the medical devices vigilance system for CE marked joint replacement implants

6
- 0006535240
- London: Medical Devices Agency; Oct. MDA Publication
- (1998) Guidance on the medical devices vigilance system for CE marked artificial heart valves. Version 1

7
- 0003421597
- London: Medical Devices Agency; Aug. MDA Publication
- (1999) Guidance on the medical devices vigilance system for CE marked breast implants. Version 1

8
- 0006598787
- London: Medical Devices Agency; Jan. MDA Publication
- (2001) Guidance on the medical devices vigilance system for CE marked coronary stents. Version 1

9
- 0006535785
- Accepted 2000 Feb 29
- Post-marketing surveillance (PMS) post market/production. NB-MED/2.12/Rec 1 Rev 11

13
- 0006626177
- London: Medical Devices Agency; Sep. MDA Publication
- (2000) Post-market surveillance of CE marked joint replacement implants including guidance to manufacturers on post-market clinical studies

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.