NHRA Bahrain

Supported by

medspero

Due to the importance of Medical Device registration, and in order to clearly explain the detailed registration process and international standards, we are pleased to invite you to the first Virtual Hands on Workshop for Medical Devices industry Regulatory Teams.

The workshop will be delivered by leading International experts in this field and include live use cases and examples via collaborative online group discussions, allowing you to gain as much knowledge and hands on experience as possible.

This four day workshop will also allow you to better understand the terminologies and concepts of registration in the Kingdom of Bahrain which have been developed based on these international standards.

AGENDA

DATE
SESSION Title
TOPICS
SPEAKER NAME
16th March
Bahrain Medical devices regulation updates
1- Overview of recent Resolution (48) of 2020
2- Updates in Medical devices registration guideline.
3- NHRA process review
4- Classification of biological, combined medical devices
5- Case studies
Eng. Nada Al Sayegh
Eng. Omar Ismaeel
Eng Abdullatif Khaled Alnaser
Saeeda Isa Al Jaberi
Eng. Wesam Mamdouh Abdelzaher
17th March
Part 1: Medspero Introduction
Part 2: Classification of medical devices
1- Fast Track MD regulation
2- Submission
3- An overview of the Classification of medical devices according to the MDR 2017/745 (22 Rules)
4- borderlines between Medical devices and other products such as PPE, Cosmetics, Medicines, Biocides
Dr. Priya Papisetty
Theresa Jeary
Monir El Azzouzi
18th March
Medical Device Regulatory Approval Process Part 1
1- Use of Standards and ISO 13485
2- Audit Planning
3- Conduct of the Audit and Audit Reporting
4- Non-Conformity Classification and required action (CAPA)
5- Examples of Non-Conformities
Theresa Jeary
Monir El Azzouzi
Malcolm Goodall
20th March
Medical Device Regulatory Approval Process Part 2
1- Use of Standards to demonstrate Conformity to Requirements
2- General Safety and Performance Requirements
3- Technical File Requirements
4- Risk Management and the ISO 14971 Standard
5- Clinical Evidence Requirements
6- Exercises
Theresa Jeary
Philip Drury

EXPERTS

Nada Ghassan Alsayegh

Eng. Nada Al Sayegh


NHRA Bahrain

Eng. Omar Ismaeel

Eng. Omar Ismaeel


NHRA Bahrain

Eng. Wesam Mamdouh Abdelzaher

Eng. Wesam Mamdouh Abdelzaher


NHRA Bahrain

Eng. Abdullatif Khaled Alnaser

Eng Abdullatif Khaled Alnaser


NHRA Bahrain

Saeeda Isa Al Jaberi

Saeeda Isa Al Jaberi


NHRA Bahrain

Theresa Jeary


Medical Device Regulatory Specialist
Regulatory & Scientific Affairs Ltd

Monir El Azzouzi


Founder and CEO
Easy Medical Device GmbH

Malcolm Goodall


Director
Malcolm Goodall Associates Limited

Dr. Priya Papisetty


Managing Director & CEO
Medspero

Dr Philip J Drury


Managing Partner
Mica Consulting Services Ltd


Previous NHRA Medical Devices Regulation Recorded Webinars