Call  +61 410 717 106

Medical Devices QMS and Regulatory Affairs Melbourne

For all your Medical Device Quality Assurance and Regulatory Affairs needs

Contact Us

Are you looking for a Medical Device consultant to register your product in EU / USA / Australia /New Zealand?

We worked for Notified Bodies as auditors for ISO 9001 and ISO 13485 (including Canadian requirements), MDD 93/42 EEC, MDR, MDSAP, CMDR (Health Canada) and 21CFR820. We are experts on creating QMS from scratch and regulatory applications (Tech files for EU and 510k submission in the USA), if you have a medical device you need to register – we will get you over the line.
With 20 years’ experience in the medical device industry, both managing Quality and Regulatory Affairs, and as an active auditor, we certainly understand the intricacies of the market. Our knowledge of the critical aspects of a business that influence product quality and compliance, means we are 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.

We are highly motivated and devoted QA/RA professionals. We list our standout traits as the following:

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

We are highly experienced and educated professionals who can be counted on to deliver the systems, documentation, and advice required, and we pride ourselves on having achieved 100% compliance for all clients we have ever worked with.

We are Qualified Auditor for ISO 9001 and ISO 13485 (including Canadian requirements), MDD 93/42 EEC, MDR, CMDR (Health Canada) and 21CFR820.

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

What others are saying …

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

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