- Accredited Small and Medium Enterprises Consultant ASMEC by AASBC: Association of Accredited Small Business Consultants and Monshaat.
- Certified “ Manager Regulatory Affairs Medical Devices International” by TÜV Rheinland & Ulm University for Applied Sciences and experienced as a regulator.
- Member of The Association of German Engineers Membership#12053894.
- Accredited Trainer by Technical and Vocational Training Corporation TVTC.
- Experienced in Medical Devices Supply Chain
- SFDA Medical Devices Marketing Authorization Applications Reviewer
- Master Degree in Biomedical Engineering, Medical Devices Usability & Ergonomics, from Germany.
- Award of the Second Saudi Annual Conference for Quality and Patient Safety (2nd Place for Research Poster).
- Experience in developing guidelines and measuring beneficiaries and stakeholder satisfaction.
- Member of the IEC- Standard Organization Saudi Mirror Technical Committee TC62 for Medical Electrical Equipment.
- Co-Author of the SFDA Requirements of Medical Devices Safe use by Healthcare Facilities.
Setting up and managing the strategy of Electrical Engineering Chapter activities and Practice in the Saudi Arabia which include:
Implementation of and managing the transformation to the Target Operational Model of Ministry of Defence Medical Supplies.
Development of medical equipment procurement process together with relevant department such as end-users, Hospitals , army and organizations such as NUPCO.
Sourcing Medical Equipment suppliers and medical equipment maintenance service providers.
Sourcing, recruiting & maintaining talents with different capabilities and skill required by department mandate.
- Preparation & Conducting of Medical Devices monitoring Plan & Identifying Laboratory Test required
- Reviewing and Assessing Medical Devices Marketing Authorization (MDMA) ( GHTF & TFA)
- Supervising and Coordinating Solving of MDMA Applicant issues.
- Conducting Workshops & Training Sessions to educate SFDA applicants regarding Medical Devices Registration Process & Requirements ( GHTF & TFA).
- Conducting Workshops & Training Sessions to educate SFDA employees regarding Medical Devices Registration Process & Requirements( GHTF & TFA).
- MDMA (Medical Devices Marketing Authorization) Application Assessor
- Coordination between Medical Devices Lab, Inspectors and Medical Devices Sector Regarding Medical Devices Monitoring Plan
- Conducting Meeting and workshops With Medical Devices Vendors Regarding Medical Devices Registration
- Conducting Training for new employees
- Managing Inquiries from Medical Devices Vendors
- Quality Improving of MDMA-applications Reviewing & Communication with vendors
-Secretary of the IEC-TC62D National Committee for Electromedical Equipment Standards
Acting Section Head of Guidelines Section in case of absence of the Section Head.
Beside the Task (Developing, Updating, and Drafting Medical Devices Guidelines) there is several achievements:
1- Drafting the Road Map for Saudi Medical Devices Inventor and Technology Transferring.
2-Leading and Closing of ("Arshedni" Platform) Project.
3- Initiative:Redesign of the Guidelines Web pages for better accessibility and usability.
4- Initiative: Creating Continuous Improvement Tools to collect electronically feedback and comments from public.
5- Initiative: Creating the First Standard Awareness Material and conducting Workshop and Presentation for universities and healthcare providers.
6- Initiative: Conducted SFDA-MDS- Lab Gap-Analysis Report for testing the safety of electrical medical devices based on international standards (IEC 60601-1).
7- Lead and Solve Different open problem in the Medical Devices Sector (e.g. Cosmetic Devices, Medical Device Storage, Bundling guidance...).
8- Cooperating with Several Department by offering technical advice regarding medical devices regulations (e.g. Standard, Surveillance..).
Conduct Study on Intensive Pulsed Light (IPL) for Cosmetic Purposes.
GE Healthcare Imaging, Neurologica, Sameer Kodak.
Teamwork
undefinedAccredited Small and Medium Enterprises Consultant ASMEC by AASBC: Association of Accredited Small Business Consultants and Monshaat.
Eng. Abdullah Alguraib
Eng. Hatim Alsaif
Prof. Dr.-Ing. Uvo M. Hölscher
Accredited Small and Medium Enterprises Consultant ASMEC by AASBC: Association of Accredited Small Business Consultants and Monshaat.
Breakthrough Supply Chain Performance Workshop ( Medical Devices)
Implementation of SFDA Medical Devices Approval Process ( Technical File Assessments TFAs & Quality Management System QMS) by UL 5 weeks
Certified “ Manager Regulatory Affairs Medical Devices International” by TÜV Rheinland & Ulm University for Applied Sciences
Certified ISO 9001:2000-Lead Auditor from BSI Management Systems Malaysia, Sdn Bhd.