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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 Affairs

Regulatory Affairs

Regulatory affairs services are critical to a medical device’s product lifecycle and therefore specialist advice must be sought before, during and after the launch of a new device. Every company that innovates in this arena seeks to offer a more effective treatment to a particular condition or disease and improve patient outcomes; therefore it’s vital that compliance and regulatory affairs responsibilities are taken seriously.
We offer the following regulatory affairs services:

  • Definition of a regulatory strategy for local or global markets including pre-market strategy, regulatory submissions and post-market compliance.
  • EU registration – we will compile technical files for your product to comply with MDD/MDR requirements.
  • TGA (Therapeutic Goods Administration) registration – the TGA is a unit of the Australian Government’s Department of Health and Aging which oversees medical device regulation in Australia.
  • Review of marketing materials for compliance based on region-related regulatory requirements.
  • Transition from MDD to MDR
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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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