
Aidan Toner-rodgers
Researcher
2
APPEARANCES
1
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Jul 21, 2026
Product Development, Validation and Authorisation
4:37
4:46
5:20

Aidan TonerGUEST
And really that's looking at either a real-world product that is on the market or perhaps being developed for the market.

Aidan TonerGUEST
It might actually be a theoretical product as well if you don't happen to work in the industry.

Emma GoodeHOST
You have a bit more, I suppose, leeway to build and the fact that you are working in many instances with a real product, if you're actually working in the industry, that you get to see every step of the way and the various steps that are required in order to bring something to market ultimately and to have a commercialised product.
Regulatory Compliance
3:59
4:09
4:23
4:35
4:55
5:07
5:36

Emma GoodeHOST
So does this module sort of refer to that and talk about the different agencies that might be overseeing these regulations?

Aidan TonerGUEST
So with our regulatory authorities, such as the HPRA here in Ireland, They would have governance over how manufactured products reach the market.

Aidan TonerGUEST
And we also have our notified bodies as well, which attributes CE marking to any device that is marketed worldwide, particularly in Europe with our CE marking.

Aidan TonerGUEST
And also, it's important to consider that we have the FDA's guidance and authorization there for different products that reach the US market, but often many of the jurisdictions as well model their regulatory needs, I suppose, on what the FDA has put out there.

Aidan TonerGUEST
It's quite a lucrative market there in the US and we We've developed a lot of products here in Ireland from early stage through to manufacturing in the US and worldwide.

Aidan TonerGUEST
And there is a move, it should be noted as well, globally to harmonize all of the regulations to sort of one set of standards for the benefit of humankind rather than just jurisdictionally.

Emma GoodeHOST
And what skills or knowledge does this micro-credential aim to deliver? So for a student who's decided to enrol in this, what can they hope to get out of this micro-credential?