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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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Changes to MDD commence soon

March 25, 2019 by Alexander Leave a Comment

  • Do you plan to submit a new MDD submission?
  • Is your current CE certificates under the Medical Devices Directive (93/42/EEC) is due for renewal?

You need to take immediate action to meet the following deadlines:

  • New CLASS III Devices – No later than March 2019
  • New CLASS IIb Devices – No later than May 2019
  • New CLASS IIa Devices – No later than March 2019
  • New CLASS I Devices – No later than August 2019

It’s important to note that you need to COMPLETE your audit by these dates, which means you need to schedule your audit asap!

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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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  • Buy ISO13485 QMS
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  • TGA Sponsor Representation
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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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