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17 w ·Translate

EU: The Latest Update on Implementation of IVDR and MDR | #mdr #ivdr #medical devices #regulatory changes

EU: The Latest Update on Implementation of IVDR and MDR

News and Politics

EU: The Latest Update on Implementation of IVDR and MDR

The Medical Devices Regulation 2017/745 (" MDR") and the In Vitro Diagnostic Devices Regulation 2017,/746 (" IVR ") are significant developments and strengthen the existing regulatory system in Europe for medical devices. The new Regulations update the EU regulat

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20 w ·Translate

UKCA Certification - https://www.i3cglobal.uk/ukca-mark-certification/
#ukca #certification #ukcacertification

UKCA Mark Certification - Medical Device Regulation in the UK

www.i3cglobal.uk

UKCA Mark Certification - Medical Device Regulation in the UK

UKCA mark certification is known as UK product marking that will be needed for products being placed on the market in Great Britain. Contact us for UKCA certification technical support service for medical and IVD devices.

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20 w ·Translate

Know the difference between FDA 510(k) and PMA - https://www.i3cglobal.uk/510k-vs-pma/
#fda #510k #pma

510k vs PMA (Premarket Notification vs Premarket Approval)

www.i3cglobal.uk

510k vs PMA (Premarket Notification vs Premarket Approval)

510k vs PMA means to prove the substantial equivalence between subject device and a predicate device. PMA, post market approval

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20 w ·Translate

Biological Safety Testing - https://www.i3cglobal.uk/what-....you-mean-by-biologic
#biologicalsafety #clinicalevaluation

What you mean by Biological Safety Testing? – I3CGLOBAL(UK)

www.i3cglobal.uk

What you mean by Biological Safety Testing? – I3CGLOBAL(UK)

Biological Safety test for a medical device is to address potential risks of the device to a patient which concentrated on the areas on the materials and manufacturing process for the device.

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20 w ·Translate

CE Mark for Medical Devices - https://www.i3cglobal.uk/ce-ma....rk-for-medical-devic
#medicaldevices #cemark #cemarking

Excellent Service for CE Mark for Medical Devices

www.i3cglobal.uk

Excellent Service for CE Mark for Medical Devices

CE mark for medical devices stands for Conformité Européenne and this is a legal requirement to place the medical device on the market in Europe.

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