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FDA Certificate

I3cglobal21 Dec, 2023Business

US FDA Certificate is a document prepared by the U.S. Food and Drug Administration, containing information about a product?s regulatory.US FDA Certificate is a document prepared by the U.S. Food and Drug Administration, containing information about a product?s regulatory.US FDA Certificate is a document prepared by the U.S. Food and Drug Administration, containing information about a product?s regulatory.

European Authorized Representative / EU Representative

I3cglobal17 Apr, 2023Business

The EU Representative is responsible for ensuring that the company has a lawful presence in the European Union. It will improve openness for the general public and healthcare professionals, as well as the coordination of information on medical devices and IVDs on the EU market. For more details visit our site!

UK Responsible Person

I3cglobal27 Jan, 2022Business

The UK responsible person would be the UK equivalent of the EU authorized representative the role of which will then disappear with regards to the UK. The UK MDR 2002 (as amended by the UK MDR 2019) details about UKRP. Medical Device CE Marking covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.

Medical Device Technical File

I3cglobal27 Nov, 2021Other

The MDR Medical Device Technical File Template must be submitted to Notified Body or Competent Authority for review and approval.Medical Device CE Marking covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.

Class III medical device

I3cglobal27 Oct, 2021Business

Class III medical device constitutes high-risk devices such as Pacemakers, Brain spatula, Copper-T IUDs, Cardiovascular sutures, etc. Permanent monitoring is required throughout its lifetime. Class III medical device constitutes high-risk devices such as Pacemakers, Brain spatula, Copper-T IUDs, Cardiovascular sutures, etc. Permanent monitoring is required throughout its lifetime.

CE Marking approval

I3cglobal22 Jul, 2021Business

CE Marking Approval of Medical Device depends on the mainly Product Quality, Technical Documentation submitted to Notified Body, Pre-Clinical Test Reports, Clinical Evaluation, User Manual / IFU & Labelling information. If you are new to the CE Marking Approval Process for Class IIa, IIb or III medical devices, below-given details will provide adequate information (in general), with various steps involved in the complete CE Certification process.

mdr clinical evaluation

I3cglobal26 Sep, 2020Business

Clinical Evaluation chapter VI of the new Medical Device Regulation 2017/745, article 61 details general safety and performance requirements to be met by all devices under normal conditions for use for the intended purpose of the device.Clinical Evaluation chapter VI of the new Medical Device Regulation 2017/745, article 61 details general safety and performance requirements to be met by all devices under normal conditions for use for the intended purpose of the device.

Medical Device Symbols

I3cglobal25 Jun, 2020Business

Medical Devices Symbols to be used with medical device labels when supplied. the Medical Device Symbols are part of the regulatory requirements.

periodic safety update report

I3cglobal06 May, 2020Business

Periodic Safety Update Report (PSUR) is prepared throughout the lifetime of moderate to high-risk device (Class IIa, IIb & III) by summarizing the results of Vigilance.