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Proposal Ar and MDR

ABC proposes to provide medical device registration and authorized representative licensing services for NHRA by creating an online system to facilitate applications. ABC will review applications with biomedical engineers to guide facilities through the registration process according to NHRA laws and regulations. The proposal aims to improve response time, system performance, staff training, and continuous upgrades to evaluate applications fairly and deliver a positive client experience.

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Mohamed Ezzat
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83 views3 pages

Proposal Ar and MDR

ABC proposes to provide medical device registration and authorized representative licensing services for NHRA by creating an online system to facilitate applications. ABC will review applications with biomedical engineers to guide facilities through the registration process according to NHRA laws and regulations. The proposal aims to improve response time, system performance, staff training, and continuous upgrades to evaluate applications fairly and deliver a positive client experience.

Uploaded by

Mohamed Ezzat
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Dear Dr.

Mariam Adhbi Al-Jalahma,


NHRA CEO.

It is our pleasure to share with you our proposal regarding Medical devices Authorized
representative Licensing services & Medical device registration services:

Whereas we are, (Adliya Business Center Co W.L.L (ABC) associated under the MOU
signed on February 1st 2021 with you (NHRA).

Regarding this cooperation, our company has created a website that will facilitate the
application process, by entering the site without any complications in progress, as our Bio-
Medical Engineers will review the applications and assist the facilities to complete the
requirements by guiding them through the laws and regulations of NHRA.

ABC BIOMEDICAL PROJECTS


PROPOSAL FOR AR/MDR
For Healthcare facility and medical devices companies in Bahrain

OVERVIEW

ABC Bio-Medical Projects is pleased to submit this proposal for services to support NHRA in
getting all medical device companies’ registration within the Kingdom of Bahrain providing
training and post-sales support for its new online system for handling the AR applications
and fulfillment system. We are committed to improving the clients'' experience through
convenience, accuracy of system, and timely delivery of evaluation reports. 

THE OBJECTIVE

• Need #1: Improve response time for all clients' applications. 


• Need #2: Improve the overall performance of the system so it handles the
application is
the correct way.
• Need #3: rapid training for staff on new system
• Need #4: Continuous modification and upgrades of the system to keep it in best
performance. 
• Need #5: Present the suitable and proper tools to evaluate the AR thus making the
system
decisions fair and reasonable.
No Description No. of Staff No. of Hour

1 Daily working hours / Engineer 1 8

2 Weekly working hours / Engineer 1 40

3 Application Reviewed Period (/App) 1 4-5

Each Application
4 (all applications will be reviewed twice for safety and quality 2 10
purposes)

5 Biomedical Staff Member 13

6 Total man-hours in week 13 520

7 Total application reviewed in week 52

8 Total application / month 13 208

Our Hardworking Team

Passion & Commitment


We have a passion for results aligned with our clients’ success, and a commitment to the
highest level of professionalism and ethical standards in everything we do.

Honesty & Openness


We have a deep intellectual honesty, and the candor to tell it like it is in straightforward
language. We remain open to the possibility that current beliefs could be wrong.

Practical
We combine bold thinking with a practical approach that focuses on getting the job done,
turning decisions into action and delivering results.
One Team
We work as one global team—both with each other and our clients—to direct our collective
energy toward achieving the extraordinary.

Kashif Saleem Shakeel Khawaja Haitham Sharaf Mohammad Ezzat


Chief Executive Officer Chief Information Officer Chief Coordinator Chief Engineer

Chief Engineer 

Sn.BME (1) Sn.BME (2) Sn.BME (3)

SBME 1 Team
Consultant 1 Consultant 2 Consultant 3 Consultant 4

SBME 2 Team
Consultant 1 Consultant 2 Consultant 3 Consultant 4

SBME 3 Team
Consultant 1 Consultant 2 Consultant 3 Consultant 4

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