MDR 2017/745 GOODBYE MDD………………….. WELCOME BACK MDD

MDR 2017/745 GOODBYE MDD………………….. WELCOME BACK MDD

                                                GOODBYE MDD…………………..          welcome back MDD……… With the commission proposing a postponement to the MDR until may 2021, it now may be possible to submit MEDICAL DEVICE CONFORMITY ASSESSMENT applications again under the mdd. Which notified bodies will accept applications again under the mdd and which will not? SPEAK TO US TODAY for further information […]

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C | M | S GONE GLOBAL

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 SolutionsMelbourne, Australia (Head Office) E: gloizou@compliancems.com.au M: +61 433 124 266 W: https://compliancems.com.au

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

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 […]

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

Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU 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 […]

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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: https://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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