Choosing the right Notified Body for certifying your medical device is important. Factors such as costs, Notified Body review times should be considered when making this decision. We work with many Notified Bodies across different[…]
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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[…]
Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more………………………………
Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more……………………………… Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop[…]
EU MDR 2017/745
GOODBYE GMDN………………….HELLO EMDN The EMDN will be the nomenclature used when registering medical devices In the Eudamed database. Although mapped to the current GMDN Nomenclature, it is stand alone and will be used in future[…]
FDA Breakthrough Device Program
The FDA Breakthrough Devices Program speeds up medical device development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
CMS will be at the AusMedtech 2024
CMS will be participating in Australia’s Medtech conference (AusMedtech 2024), which will be held on May 22-23 in Adelaide. Come talk to us at booth 13. George will also be chairing a panel discussion on[…]
C | M | S GONE GLOBAL
Need Australian TGA / European EU Rep or Asian Medical Device Representation? MEDICAL DEVICES LICENSE HOLDING / TGA SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check out our website[…]
CMS can help you with your internal audit.
CMS can help you with your internal audit. Contact us to book your next internal audit. We are also hosting a three-day Auditor training session on May 14-16 2024. Contact us to book your spot.
The MDCG issued updated guidance, MDCG 2024-3.
The MDCG issued updated guidance MDCG 2024-3 on the content of clinical investigation plans for medical devices. It aims to assist sponsors with the CIP content and to pre-empt queries from regulatory authorities during application[…]
TGA ARTG Medical Device Sponsorship
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[…]