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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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Buy ISO13485 QMS

Buy ISO13485 QMS Template

You can buy and download the template ISO13485 Quality Management System which includes generic QMS procedures and forms.
Ideal for start-up companies looking for being certified for the first time.
This QMS template will suit small to medium organizations, looking to implement ISO 13485 for the first time, while looking for a cost-effective and efficient option. You’ll have to have employees who are familiar with Quality Management and will be able to implement and adjust the QMS template to your organization’s needs.

You can purchase the whole QMS or a separate template as required.

This QMS complies with ISO13485 / 21CFR820 / EU MDR.

Please contact us for a quote at alexander@medicalqms.com.au

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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
  • Buy ISO13485 QMS
  • 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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