Summary of professional experience

Ahmad has a strong background in medical devices in Regulatory Affairs and Quality Management.

He worked for several years as head of QM/RA, PRRC (MDR) and QM Rep. (EN ISO 13485).

He was the lead auditor in internal as well as supplier audits.

Ahmad has deep knowledge of risk management and medical device product life cycles. He also supported R&D projects to formulate a sound regulatory strategy.

He specializes in process optimization and automation leveraging methods like Lean Six Sigma and machine learning.

He was responsible for raising awareness and training company employees in both quality and regulatory matters

Services

• Building, evaluating, and reworking regulatory strategy, based on regulatory requirements of target markets, with top management, to ensure:
• Optimal time to market
• Scalability towards future markets
• Reduction of future and current costs
• Building, evaluating, auditing and reworking QMS according to EN ISO 13485 and 21 CFR part 820, to ensure:
• Compliance with regulatory, market as well internal company requirements
• Added value through digital, lean and scalable processes
• Alignment of vision throughout the entire company
• Consulting in regulatory and quality integration across matrix structure or M&A
• Consulting in Risk management systems according to EN ISO 14971
• Consulting in process and workflow optimization and control, focusing on lean six sigma, and automation.
• Training in regulatory, quality and data-related topics

Field of Expertise

• Regulatory Strategy
• MDR
• Audits
• Risk Management
• Quality Policy & objectives
• QM (ISO 13485)
• Management Reviews
• Training