AU > Events > Quality Compliance in Highly Controlled Medical Device Industrial Environment

Quality Compliance in Highly Controlled Medical Device Industrial Environment

  • Date & Time:
    • May 16, 2022
    • 12:30 P.M. - 02:00 P.M.
  • Venue:
    • MS Teams - College of Engineering
Seminar / Workshop

Quality Compliance in Highly Controlled Medical Device Industrial Environment

About this Topic

Due to its immense impact on public safety, manufacturing of medical devices is one of the most stringent industries controlled by authorities, and manufacturers shall conform to the regulatory requirements of the region in which a medical device is being marketed for use. Therefore, Medtech companies must establish, follow and maintain quality systems assuring compliance with the laws; leading to designing/manufacturing safe and effective devices reliable for use as intended for. This can be only done by ensuring a controllable lean sustainable environment maintaining the expected quality standards of tech. industries!

Speaker

Ali Khachab, PhD, QM/PMP

Senior Quality Compliance Manager

Dr. Ali Khachab is a senior quality compliance manager with 12+ years of experience in the medical device industry inc. 8+ years in regulatory affairs, product development. Dr. Ali Khachab graduated in 2013 with a PhD in medical technology before conducting a postdoc in orthopaedic clinical research, both at RWTH Aachen University, Germany. Since 2018, he acts as Regulatory Affairs Manager at Biotronik AG, Switzerland, a pioneer and global org. committed to helping people with heart and blood vessel diseases. Dr. Ali Khachab has a six sigma -green belt-, and acts as a lead auditor.

Acted as a project manager for several R&D medical device projects leading to product launch of cardiovascular devices still available on global markets today (EU, US, JP, AU, etc.). Extensive experience in external audits such as FDA, EU etc. Since 2018, he leads the MDR project inc. 70+ employees to implement the new EU regulation with a budget exceeding 10 M€!

Session Details

Date
16 May 2022 (Monday)
Time
12:30 PM – 2:00 PM
Venue
MS Teams
Online