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QMS

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IVDR, MDR

Updated MDCG 2021-25 on MDR legacy requirements

MDCG just updated its guidance document on the application of MDR requirements to legacy devices and to devices placed on the market prior to 26…

October 17, 2024
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Simona Varrella 2024-10-17T17:38:19+02:00
MDR

MDR QMS compliance: Necessary elements by 2024

Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One being to have set up a Quality Management System (QMS)…

June 14, 2023
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Pablo De Mingo Monge 2023-06-14T13:00:07+02:00
IVDR, MDR

Q&A on extension of the MDR transitional period and removal of the “sell off” period

Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR), the European Commission published a Q&A document to facilitate the…

March 28, 2023
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Simona Varrella 2023-03-28T13:19:16+02:00
MDR

MDR: Harmonised standards for QMS and risk management

Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of…

May 17, 2022
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Simona Varrella 2022-05-17T17:53:44+02:00
IVDR

IVDR: Harmonised standards for QMS and risk management

May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will…

May 12, 2022
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Simona Varrella 2022-05-12T12:45:45+02:00
MDR

Legacy devices: new MDCG guidance on NB surveillance & QMS

The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to be performed by notified bodies while carrying out their surveillance…

February 16, 2022
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regulatory26@obelis.net 2022-02-16T18:05:44+01:00

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