Please recommend any good training courses for Medical Device Regulations

[Smileyk]

Can anyone recommend any good training courses for medical device regulations?

Also has anyone used the WMDO website and if so can you offer a review?

Thanks!

 

[J0anne]

Re: Medical Device Training??

The best way to learn is by reading and applying the regulations.

Cranfield University (England) does a couple of medical device related degrees and short courses which are quite good.

I don't know what the WDMO website is. Do you have a link?

 

[mihzago]

Re: Medical Device Training??

what regulations do you have in mind i.e. which region?
are you looking for free or paid courses? computer based or in-person?

FDA CDRH Learn has a lot of decent (though a bit boring) training materials, if you're interested in US regulations.
Many consulting sites have some free training, in addition to paid. Try Emergo group or medicaldeviceacademy.com

 

[Smileyk]

Re: Medical Device Training??

I can't post a link but it's WMDO dot org.

Thanks for the help, regions initially are EU and USA but Asia Pac are on the list too. We do EU now but I think there is more we don't understand so I was hoping to find a computer based style course so we can check that we are doing things correctly (we have an NB but I think there are "holes" in what we do that they haven't picked up on - namely usability).

 

[Marcelo]

Re: Medical Device Training??

Some people here (including myself) can also provide training also, in particular to specific aspects such as usability as mentioned.

As a suggestion, you may also seek training about medical device regulations concepts that explains the basis for medical device regulations in general, this would let you understand most of the regulations that exists right now in a general way. This is a kind of training I think is fundamental but that most people lack.

 

[Marcelo]

Re: Medical Device Training??

You also may seek training in medical device design. Design aspects such as usability/human factors are basic design requirements that are independent of regulations, but at some point in time may be a focus or part of any regulation (for an example of a lit of basic design expectations, see this list by Pugh - (broken link removed)).

 

[Philip B]

Re: Medical Device Training??

NSF in the UK are running a medical device regulatory framework course (I'm currently on this). It is a post-graduate course with options of four modules (certificate), eight modules (diploma) and eight modules plus a project (MSc degree). The modular approach allows flexibility, I'm doing two modules per academic year. The course is designed to meet the requirements for a 'qualified person' within manufacturers. Please see NSF website for further details (sorry, the forum won't allow me to post a link, please PM me if you would like further details).

 

[Ajit Basrur]

Re: Medical Device Training??

You also may seek training in medical device design. Design aspects such as usability/human factors are basic design requirements that are independent of regulations, but at some point in time may be a focus or part of any regulation (for an example of a lit of basic design expectations, see this list by Pugh - (broken link removed)).

Marcelo, can you please fix the link - unable to open ? Thanks!

 

[Marcelo]

Re: Medical Device Training??

Marcelo, can you please fix the link - unable to open ? Thanks!

It's not there anymore, I uploaded the image.