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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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Regulatory and QMS Training

For all training, a certificate of participation will be issued.
We offer the following training courses:

Implementation of QMS in compliance with ISO13485/21CFR820/MDR/MDSAP training

During this training, you will learn:

  • How to create a QMS implementation plan
  • What is a Quality Manual and Quality Policy
  • Establishment of QMS procedures – which procedures are mandatory
  • Risk-based approach to QMS processes

Specific QMS training

  • Supplier evaluation and management
  • Effective Corrective Action
  • Other custom training as required

Product-specific standards training

  • Application of Risk Management – ISO 14971
  • Medical device software – Software life cycle processes – IEC 62304

Regulatory Training

  • Application of EU MDR – a creation of the Technical File

Internal Auditor course for ISO 13485/MDSAP

During this course, you will learn:

  • Creation of internal audit schedule
  • Internal audit process and implementation for compliance purposes
  • Audit Report – Report writing + information that must be included in the audit report
  • Response and closeout of non-conformances
For all training, a certificate of participation will be issued.
Get Free Quote

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

Get In Touch

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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