[organization name]

Summary of Safety and Clinical Performance for [medical device]

** FREE PREVIEW VERSION **

Document information

Version:

Created by:

Approved by:

Date of version:

Change history
Date Version Created by Description of change

Summary of Safety and Clinical Performance ver. [version] from [date] Page 1 of 3

©2020 This template may be used by clients of Advisera Expert Solutions Ltd. www.advisera.com in accordance with the License
Agreement.
 [organization name]

Table of Contents
1. IDENTIFICATION OF THE DEVICE............................................................................................................ 3
1.1. IDENTIFICATION OF DEVICE OR DEVICE FAMILY.....................................................................................3
1.2. IDENTIFICATION OF MANUFACTURER....................................................................................................3
1.3. DEVICE DESCRIPTION...............................................................................................................................3
1.4. INTENDED PURPOSE................................................................................................................................4

2. LIST OF APPLICABLE STANDARDS........................................................................................................... 4

3. SUMMARY OF RESIDUAL RISKS.............................................................................................................. 4

4. CLINICAL EVALUATION........................................................................................................................... 5

5. POST-MARKET CLINICAL FOLLOW UP..................................................................................................... 5

Summary of Safety and Clinical Performance ver. [version] from [date] Page 2 of 3

©2020 This template may be used by clients of Advisera Expert Solutions Ltd. www.advisera.com in accordance with the License
Agreement.
 [organization name]

1. Identification of the device

1.1. Identification of device or device family

Accessories

Classification …
Identification,
UDI number

1.2. Identification of manufacturer

** END OF FREE PREVIEW **

To download full version of this document click here:

https://advisera.com/13485academy/documentation/summary-of-safety-and-clinical-performance/

Summary of Safety and Clinical Performance ver. [version] from [date] Page 3 of 3

©2020 This template may be used by clients of Advisera Expert Solutions Ltd. www.advisera.com in accordance with the License
Agreement.