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Med QMS

Medical Devices QMS and Regulatory Affairs Melbourne

For all your Medical Device Quality Assurance and Regulatory Affairs needs

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Get It Right First Time, Every Time.

Get expert advice and implementation at every point in the product life cycle
We help established companies as well as start-ups with all their medical device Quality Assurance and Regulatory Affairs needs.
Our aim is to provide a personalised and exceptional service.
Our Services

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QMS Services and Audits
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Regulatory Affairs
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medical device qms setup
QMS Setup
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medical device regulatory and qms training
Regulatory and QMS Training
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medical device TGA sponsor representation
TGA Sponsor Representation
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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

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

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

Contact us for a customised quote for all your Quality Assurance and Regulatory Affairs requirements.


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Med QMS

For all your Quality Assurance and Regulatory Affairs requirements.

+61 410 717 106

alexander@medicalqms.com.au

Melbourne based

Elsternwick VIC 3185
Australia

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Our Services

  • All Services
  • QMS Services and Audits
  • Regulatory Affairs
  • QMS Setup
  • Regulatory and QMS Training
  • TGA Sponsor Representation
News and Updates

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About

With 20 years’ experience in the medical device industry, both managing Quality, and Regulatory Affairs and as an active auditor, we can be counted on to deliver the systems, documentation and advice required.
We pride ourselves on having achieved 100% compliance for all our clients. Continue reading …

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