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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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QMS Setup

Medical Device Quality System Setup
ISO 13485:2016 and 21CFR820

quality system
Beneficial for start-up companies who are new to medical device regulations, this service delivers a systematic approach that will take you from zero to compliant. We’ll create an implementation plan and then go ahead and set up all the necessary structures and documentation. Our advice is considered, methodical and pragmatic – you’ll know where you stand every step of the way.

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


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

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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
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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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