Quality Procedures

Question 1

ST-00013

Answer 1

Sterilization Process Assignment

Question 2

SOP-00096

Answer 2

Sterilization Evaluation Study

Question 3

SOP-00050

Answer 3

Corporate Design Control Procedure

Question 4

SOP-00020

Answer 4

Device Master Record

Question 5

SOP-00020-F-00006

Answer 5

Device Specification Sheet Template

Question 6

SOP-00003

Answer 6

Vendor Evaluation Procedure

Question 7

SOP-00219

Answer 7

Medline Human Factors & Usability Framework

Question 8

SOP-00003-A-00003

Answer 8

Vendor Setup Process Flowchart - Medline Labeled Products

Question 9

SOP-00050-F-00007

Answer 9

Design Transfer Agreement

Question 10

SOP-00050-F-00007

Answer 10

Design Transfer Agreement

Question 11

SOP-00050-F-00015

Answer 11

Design Transfer Agreement Letter

Question 12

SOP-00099

Answer 12

Risk Management Procedure for Medical Devices

Question 13

LAB-00166-F-00003

Answer 13

DVV Lab Request for Analysis

Question 14

SOP-00234-A-00002

Answer 14

Drug OUS Guidance Document (Drug Vigilance)

Question 15

RA-00001

Answer 15

Label Approval and Proofing Process

Question 16

RA-00001-A-00035

Answer 16

Min Requirements for Production Artwork Release with Deviation