Medical Device Single Audit Program (MDSAP) – TGA and more…………….

Medical Device Single Audit Program (MDSAP) – TGA and more…………….

Medical Device Single Audit Program (MDSAP) – TGA and more…………………… Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical […]

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Cosmetics GMP for Export Purposes (ISO 22716) – Responsible Person

C | M | S can now act as your European responsible Person. If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this regulation? All cosmetic products exported to Europe/Asia/NZ will have to be produced according […]

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TGA Australian Medical Device Sponsorship / License Holding

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you […]

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Need TGA / European or Asian Medical Device Representation?

MEDICAL DEVICES LICENSE HOLDING / SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation……………….via contact us.   Compliance Management Solutions Melbourne, Australia (Head Office) E: gloizou@compliancems.com.au M: +61 433 124 266 W: http://compliancems.com.au

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ISO 45001 Occupational health and safety

https://www.iso.org/files/live/sites/isoorg/files/standards/docs/en/iso_45001_briefing_note_EN.pdf  

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Need TGA / European or Asian Medical Device Representation?

MEDICAL DEVICES LICENSE HOLDING / SPONSORSHIP Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation……………….via contact us.   Compliance Management Solutions Melbourne, Australia (Head Office) E: gloizou@compliancems.com.au M: +61 433 124 266 W: http://compliancems.com.au

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TGA Australian Medical Device Sponsorship / License Holding

As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you […]

Read More

Cosmetics GMP for Export Purposes (ISO 22716)

If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this regulation? All cosmetic products exported to Europe/Asia/NZ will have to be produced according to Good Manufacturing Practices. Cosmetics Good Manufacturing Practices (GMP) is one of the […]

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MDSAP – Medical Device Single Audit Program

Medical Device Single Audit Program (MDSAP) – TGA Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single […]

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MDSAP – Medical Device Single Audit Program

Medical Device Single Audit Program (MDSAP) – TGA Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single […]

Read More