Demo Request Form

Step1
Demo Plan

The objective is sending Demo Devices to Al Dana Medical our Distributor in Qatar to be used
for Demonstration/Marketing purposes

● The devices shall be tagged as a Demo device (Not for Sale)

● A (Demo) Account needs to be created.
● The companion app needs to be downloaded on the mobile phones (in stock with
Peter)
● The service must be activated for six months.
● The device must be returned to Brighter when the Demonstration is finished (or the
agreement is terminated )
● Al Dana must sign the Demo agreement.

Quantity Needed

Demo devices

● One Actiste startup kit to be activated and paired with the Demo Account
● One Actiste Mini startup kit to be activated and paired with the Demo Account

Devices will use staging firmware (not production environment), and be marked “Demo
device, not for clinical use”. We can send with dated IFU and note since this is only for Al
Dana use. Abdul Alashawill keep track of all demo device SN. Marie will write an
exemption to the delivery stop for Actiste, getting information on what is sent from Abdul
Alasha.

Training devices

● 2 Actiste Mini Startup Kit for training Purpose (Hospital and Pharmacies) .
● 2 Actiste Startup Kit for training Purpose (Hospital and Pharmacies) .
● 2 Mobile phones to download the companion app on it. (We can use an Al Dana
team mobile phone if applicable)

Devices will use staging firmware (not production environment), and be marked “Demo
device, not for clinical use” It will also be marked “This device is and remains the
property of Brighter AB (publ) [ADRESS]”. Abdul Alashawill keep track of all demo
device SN.
Step 2

Local regulations

● The Medical device is approved.

● Data storage and processing is approved
● Radio Transmission approved
● Permanent roaming is allowed

Step 3

Risk Analysis

Risk

Al Dana are trained only virtually on how to use the Actiste .

Mitigation action

After they receive the device we will do another online training.

Shiju will do a face to face Demonstration when he travel to Qatar
Residual risk level (after mitigation)?

Risk
Data from the demo could pollute the real data in Brighter’s system.

Mitigation action
Keep track of the serial numbers of the Actiste devices and inform Brighter operation function so that they
can ensure that the data is managed properly.
Residual risk level (after mitigation)?
 Step 4
Approve Step1-3

Note:- This step can be done in the Product counsel meeting

Prepared by:-
Wael Kaddourah
Date of approval 8-11-2021

Approved by:-
Johan Möller Yes Date of approval 11-11-2021

Step 5

Demo Deployment Plan & agreement

The authorized representative in Qatar will sign the below agreement and share a scanned copy
with Brighter.

Demo Agreement Draft

I confirm that I have received the below Items Below.

1. Actiste Mini Startup Kit with the serial number of (..................................................)

2. Actiste Startup Kit with the serial number of (..................................................)

I have been trained by Brighter on how to do the demonstration of the ADMS.

I agree and undertake the following:-

● The device(s) will be used for demonstration purposes only and NOT for Clinical use,
complying with all instructions given by Brighter.
● The importer is responsible for complying with all local laws and regulations, including
the legality of importing, demonstrating and or marketing the device(s) in the jurisdiction,
including but not limited to laws relating to:
 ○ Medical devices.
■ Including Actiste, Actiste mini with accessories (Test strips, lancets &
needles).
○ Radio transmission devices.
○ Storage of any personal or medical data in the device(s) or in the ADMS
● The devices will be returned to Brighter on demand or within 6 months after the date of
signing this agreement.
● No labels on the device(s) will be removed or obscured.
● Brighter is not responsible for any loss or damage suffered by any person that may arise
due to use or abuse of the device(s) and we will indemnify and hold harmless Brighter
against any injury or loss suffered by any relevant person affected.

[Note:- Brighter will supply appropriate Mobile phones if needed]

Agreed & Received By:- Date:-

Approved By:- Date:-

Step 6

Prepare the Demo

 Step 7

Return the Demo Device