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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 Solution Services

Gap Analysis for an existing QMS

We help companies first to identify gaps in their current QMS and then to upgrade it to comply with ISO 13485:2016 requirements.

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Setup Standard Operating Processes and Procedures

If all you need is a specific QMS process procedure but you don’t know where to begin or simply don’t have time for it this service is for you.

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Validation Activities

We help with process validation, by reviewing your manufacturing process and providing advice, including writing a validation protocol, to ensure the process is properly validated and complies with all relevant regulatory requirements.
We also perform software validation for all software tools used by the business.

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Risk Assessment

Having extensive experience with various medical devices, we provide assistance with medical device related risk assessment in compliance with ISO 14971.

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QMS Training

We provide separate training for QMS processes for your employees, such us:

  • Control of Documents and Records
  • Design Control
  • Supplier evaluation
  • Risk Management for medical devices
  • Internal Audit for ISO 13485:2016
  • Regulatory requirements for marketing materials
  • Change Control
  • CAPA (Corrective and Preventive Action)
  • Reporting to Regulatory Authorities (Notified Bodies and FDA)

We will customize training activities for your company needs.
For more details please contact us

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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
  • 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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