Afleveringen
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The demise of LRQA this week signals that the crisis in Notified Body resource ahead of the Medical Device Regulation has gone critical.
MeddiQuest's Neil R Armstrong looks at the original concept and history of European Medical Device Notified Bodies to see if this can shed some light on why in the run-up to MDR implementation the Commission's system is failing industry. -
NB's hit hard by the Brexit shambles! Here is the latest!
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Zijn er afleveringen die ontbreken?
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The Brexit Saga continues and as we have predicted a no deal Brexit seems highly likely!
So we will cover what the Governments lack of planning and negotiation has brought/taken away from the table. -
This episode we take on the US and cover FDA, Apple Watch apps, the infamous government shut down as well as touch on new light shed on the Brexit disaster
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The BIG ONE!
Our predictions of the impact of Brexit on the industry from what we know already and how we think different parts of the business will be effected and how more to the point how regulation will be effected! -
A "who, what, why, and where" on adults with in regulatory affairs for medical devices.
Everything from the process to "audit etiquette" -
In this episode we will be looking at what exactly a 510k is and how they are used in US regulation
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In this episode myself and Neil will cover the aspects of clinical evaluation of medical devices and the role of regulatory affairs within this
