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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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News and Updates

August 10, 2020

Biggest mistakes during Medical Devices design phase

Usually, a new medical device starts with an idea. Idea created by an engineer who works in the industry or a medical personnel/clinician who found a new solution for an existing problem or a new way

Category iconQuality and Regulatory Market Updates

quality system and regulatory affairs

November 1, 2019

Corrective and Preventive Action (CAPA) – The three most common mistakes

Are you familiar with the CAPA process? Having a Corrective and Preventive Action (CAPA) process is a mandatory requirement of most Quality Management Systems standards. If used correctly,

Category iconArticle,  CAPA

July 27, 2019

MDR/IVDR Update

A Call out to all self-certified Class I Medical Device Manufacturers Are you a self-certified Class I Medical Device Manufacturers? In the case of Up-classification under MDR/IVDR, after 26th of May

Category iconQuality and Regulatory Market Updates

March 25, 2019

Changes to MDD commence soon

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

Category iconQuality and Regulatory Market Updates

March 25, 2019

FDA guidance on Medical Devices with Animal origin materials

FDA releases final guidance on Medical Devices containing materials of animal origin. FDA guidance PDF

Category iconQuality and Regulatory Market Updates

March 5, 2019

ISO 13485:2016 transition period ending

As per TGA reminder, ISO 13485:2016 transition period ends on 1 March 2019. From 1 March 2019, conformity assessment applications must be supported by evidence that a quality management system has

Category iconQuality and Regulatory Market Updates

February 11, 2019

Design for new product safety marking in UK

UK Government published the design for the UK marking that would apply to certain products sold in the UK if the UK leaves the EU without a

Category iconQuality and Regulatory Market Updates

February 7, 2019

Urgent BREXIT Implications for Market Access

BSI press release - Urgent BREXIT Implications for Market Access. BSI strongly recommend manufacturers migrate their existing BSI UK NB (0086) CE certificates to BSI NL NB (2797) as a matter of

Category iconQuality and Regulatory Market Updates

February 6, 2019

Medical Device Single Audit Program (MDSAP)

As an outcome of the Medical Device Single Audit Program (MDSAP) Pilot, FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections.

Category iconQuality and Regulatory Market Updates

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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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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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