For all your Medical Device Quality Assurance and Regulatory Affairs needs

We’re not only Quality Management Consultants, we’re also active Auditors, which means we know EXACTLY what’s required to take your medical device to market quickly and effectively. Medical QMS is proud to have achieved accreditation for 100% of our clients.

We’re up to date with all changes in this area. We not only provide the advice you need but also create the exact systems and documentation required to get the auditor to say YES!

Whether you’ve previously failed an audit, are looking to expand into new markets and need to satisfy other regulatory bodies, or are a start-up with a fresh idea, Medical QMS can assist.


tickAustralia
tickUSA
tickEurope
tickCanada

Our Services

We can assist you with all your Quality Assurance and Regulatory Affairs requirements. Our services include -

  • Medical Device Quality System Setup
    ISO 13485:2016 and 21CFR820
  • QMS Solution
  • QMS Internal audit
  • QMS Pre-audit
  • QMS Supplier audit
  • MDSAP Audit
  • Regulatory Affairs
  • Australian TGA Sponsor Representation for Medical Device Companies

What others are saying …

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. 
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. 
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.
 

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


ISO 9001 ISO 13485:2016 MDD 93/42 EEC / MDR CMDR (Health Canada) 21CFR820