לדף הבית |
דפי מידע |
צור קשר |
ISO 13485 |
תקינה לציוד רפואי בארה"ב |
|
FDA Site |
|
Medical Device Regulations |
|
Search CFR
21 Datatbase |
|
Part
807 - Registration and Device Listing |
|
21 CFR Part 820 -
Quality System Regulation |
| Z |
Design
Control Guidanc |
|
Device Master Record |
Device Master
Record - נוהל דוגמא |
|
510K |
510K
Screening Checklist |
Listing
of CDRH Substantially Equivalent (SE) 510(k) |
|
CDRH Compliance
Activities |
|
21
CFR Part 11 - Electronic Records |
21 CFR
Part 11 - Electronic Records |
|
Labeling
Requirements |
|
Medical
Device Recalls |
|
סקירה
כללית |
|
ISO 13485 |
X |
