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:
- Technical expert
- Creative thinker
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.
MDD 93/42 EEC / MDR
CMDR (Health Canada)
What others are saying …
I would gladly work with Alexander in the future.
Product Ideation Consultant
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.