×

Notified Bodies

Train-derailing

And so starts the MDR/Brexit fallout… First LRQA and now QS Zurich fall by the wayside

By Luis Jimenez | 27 June, 2019
Breaking News: As of June 13th, Lloyds Register Quality Assurance (LRQA) withdrew from MDD and IVDD services (see the announcement here). It's official, the first notified body based in UK...
TrainXstation

Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?

By Luis Jimenez | 3 December, 2018
As the implementation journey for the EU MDR/IVDR passes the halfway point, we provide an update to the current state of play and the impact on our industry. Many, if...

Search

Recent Posts

Some Class I Device Transitions Extended – MDR

Feb 3, 2020

And out they go…BREXIT is final! But what about Australia?

Jan 30, 2020

TGA acceptance of international device reviews – clearing the fog

Dec 20, 2019

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

Dec 19, 2019

A single review program for medical devices?

Dec 2, 2019

The door to Europe is closed – so where else should I look?

Dec 2, 2019

Categories

Categories

Archives

Archives

Archives

Tags

3D 510(k) AIMD APAC Australia Biocompatibility Brexit CE CE Certificates clinical trials de novo distribution EU Europe FDA GHTF guidance Harmonization IMDRF IVD IVDD IVDR MDD MDR MDSAP medical device Medical Device Regulations medical devices medicines MHRA New Zealand Notified Bodies PMA PMDA postmarket private health insurance QMS Quality Systems Reform Reimbursement SaMD Software standards TGA UDI
Translate »