Design V&V courses

#1
Hello, Looking for a course that may help me become better at Verification & Validation activities for medical devices and IVDs? I see multiple Design Controls courses but want a more focused one. Thanks
 
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yodon

Leader
Super Moderator
#2
Honestly, that's a really tall order. It covers everything from planning to protocol development to techniques for specific disciplines (e.g., driving an oscilloscope for electrical testing, writing code for automated testing, using calibrated equipment for mechanical testing, chemistry testing with IVDs, dealing with study subjects for HFE testing, and on and on). And that's not even getting into how you review requirements to ensure testability.

I think one of the most important aspects in V&V is protocol development. Efficiently testing the requirement (and avoiding testing the design). But I don't know of any courses that would provide such training.
 

yodon

Leader
Super Moderator
#4
How about asking your chief designer to show you how product design V&V is meant to be specified, planned, done and recorded?
Ha... none of our folks that might fit that description would want to touch V&V. They might give a cursory overview (probably not more than "verification is demonstrating that the requirements are met and validation is demonstrating that the user needs and intended use are met.") :)
 

John Broomfield

Leader
Super Moderator
#5
Ha... none of our folks that might fit that description would want to touch V&V. They might give a cursory overview (probably not more than "verification is demonstrating that the requirements are met and validation is demonstrating that the user needs and intended use are met.") :)
Then, may I suggest, that better verification and validation of design is starting at the wrong end of the design process?
 

yodon

Leader
Super Moderator
#6
Then, may I suggest, that better verification and validation of design is starting at the wrong end of the design process?
Valid question... and don't get me wrong, our design leads are great to work with and do appreciate the value that we, on the V&V team, provide - both early on in hammering out (testable) requirements and later in flushing out bugs. But they wouldn't be the best to teach any V&V courses.
 

Ronen E

Problem Solver
Moderator
#7
Hello, Looking for a course that may help me become better at Verification & Validation activities for medical devices and IVDs? I see multiple Design Controls courses but want a more focused one. Thanks
I think a course will give you a great feeling and maybe a certificate, but it won't really help you. As pointed out, the scope is too wide and you probably need something tailored to be effective. I'd venture a guess that all courses available out there will give you broad, shallow background, and cover a lot of topics you'll never need while missing out on some of the ones most critical to you.

If you are after that sort of broad, generic knowledge, I'd focus on finding good books and videos. If, on the other hand, you want to hit the nail on the head (I noticed in your profile that you are in IVD, so I'd focus on that; verifying orthopedic implants would obviously be different), I'd recommend low-intensity mentoring over a long period of time (say, 6-12 months). Work on real-world examples and issues with someone experienced, and learn through doing (supplementing via guided, focused reading will help consolidate and generalize). If no one in your company is available to mentor you in that manner, look for someone external.

Where are you located, geographically?
 

Randy

Super Moderator
#9
Honestly, that's a really tall order.
Actually it's not a tall order, I created such a course a few years ago at the request of a client to create and deliver an 8 hour course covering then :ISO 9001:2008 - 7.3, that was eventually put into and delivered into the public domain until the 2015 revision came out.

The client wanted something for their design engineers from initial concept to reality success for a product outside their industry (large industrial HVAC) and examples where there were historical design failures and successes.

In the end, the HVAC designers were so pleased with being able to look at similar happenings totally outside their industry we (the training organization I was a part of) got more business directly from the word of mouth recommendation to others from those engineers.

Here we seem to have another subject where there appears to be a lack of ability or desire to understand and accept out of box thinking to help resolve their in the box problems partially deriving the solutions from similar circumstances.
 

Ronen E

Problem Solver
Moderator
#10
an 8 hour course
Good on you for reaching the goal of a happy customer (I'm not being sarcastic) - your actions were evidently effective. However, I think that an 8h course covering "Verification & Validation activities for medical devices and IVDs" (in our OP's words) will end up as a nice (effective?) introduction. Maybe that's all they need. But for a more in-depth understanding I think they will need at least double that, and I would definitely NOT implement it as 1-2-day dense workshop, not even as 2 or 3 sessions but rather as 2-3h lessons spaced apart so they could actually practice in between.
 
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