About

Alexander Zisman – Director and Founder of MED QMS

Alexander has always been trusted to get the job done. Whether it’s catching a fish in a competition, cheering from the sidelines at one of his boys’ soccer games or ensuring his clients are compliant, Alexander commits 100% to the task and ensures a result.

Having moved to the sunny shores of Australia from Russia, via Israel, Alexander has proven to be an asset to every team he’s been involved with, regardless of the environment. In fact, it is his ability to integrate and communicate with clients and team members across cultures that has seen him become a sought after Quality Assurance and Regulatory Consultant by companies seeking to develop regulatory strategies for entry into the EU, Australian, Canadian and US markets.

With 20 years’ experience in the medical device industry, both managing Quality and Regulatory Affairs and as an active auditor, Alexander certainly understands the intricacies of the market. His knowledge of the critical aspects of a business that influence product quality and compliance, means he is particularly focused on achieving a balance between risk and commercial rewards. Ensuring the Quality Management System supports the business needs as well as meets regulatory compliance goes without saying.

Alexander is a highly motivated and devoted QA/RA professional, who lists his standout traits as the following:

• Tenacious
• Punctual
• Straight-talker
• Detail-oriented
• Technical expert
• Creative thinker
• Accurate
• Flexible

Alexander is an experienced and educated professional who can be counted on to deliver the systems, documentation and advice required, and he prides himself on having achieved 100% compliance for all clients he has ever worked with.

Alexander holds a Bachelor of Electronic Engineering from the Israel Institute of Technology, Certified Quality Engineer by ALD College and Qualified Auditor for ISO 9001 and ISO 13485 (including Canadian requirements), MDD 93/42 EEC, MDR, CMDR (Health Canada) and 21CFR820.

Australia

USA

Europe

Canada

What others are saying …

Angela Drew

 I worked with Alexander to get regulatory clearance in US and EU for our products. Alexander was often thinking outside of the box, offering creative solutions, suggesting improvements and providing helpful information throughout the project and in a timely fashion. His extensive experience in regulatory and QMS allows him to prevent issues before they arise.
I would gladly work with Alexander in the future. 

Camargo Pharmaceutical Services

Product Ideation Consultant

Michael Mizrachi

 Alexander is a knowledgeable and devoted QA and QC professional, always striving and succeeding to find the golden path that ensures compliance and continuous improvement while maintaining a pragmatical approach considering real-life constraints.
Alexander is also a people's person who has excellent communication and socializing skills and was very likable by everyone.
I'd love to work with Alexander in the future, and he has my warmest recommendations. 

Philips Medical System Technologies

Q&R Director

Ivy Cheng

 Alexander has extensive knowledge of Quality Systems and Regulatory Requirements for Medical Devices. With Alexander on my team, I always had peace of mind knowing Alexander will deliver a well thought high-quality solution that will support my company’s needs. 

Regulatory Affairs & Quality Professional