A question for software engineers. Can you draft an SRS for an existing commercial product within 24 hours? That is, can one be created that would withstand scrutiny against ISO 13485?
Serious answers only please.
2007-09-28 05:58:20 · 3 answers · asked by Flying_Bears_are_Cool 1 in Science & Mathematics ➔ Engineering
No. Do it right or the FDA will fine you, put you on probation, and shut you down if you don't comply.
ROTFL!
Medical products are serious business. You're talking about human life here.
If you don't like the regulatory work and documentation, go into another field. Explain to your boss that the reason medical products cost a lot is that they require a lot of time and resources to develop.
Oh, BTW, you can't test a product in 24 hours either.
2007-09-28 08:36:44 · answer #1 · answered by Anonymous · 1⤊ 0⤋
If you are starting from ground zero, not a prayer. These, even for "simple" products can take upwards of a month - many months for more complicated products.
It is possible that there exists an exceptionally compatible SRS for a very, very closely related product and using that as a starting point, it would be conceivable...not likely, but conceivable it could be done.
But think about it. If you were handed a written SRS, it would probably take you 24 hours just to type it in.
2007-09-28 13:15:25 · answer #2 · answered by Mind Bender 5 · 1⤊ 0⤋
A lot of that depends on the complexity of the product and how much real content you'd need. Maybe if you could make a lot of references to other, existing, specs. But I kinda doubt it. And, if you did, it would be nothing short of a 3-ring circus doing a ton of cut 'n paste and it's an absolute certainty that it would be full of errors.
Some bright lad in upper management come up with this?
Doug
2007-09-28 13:29:23 · answer #3 · answered by doug_donaghue 7 · 1⤊ 0⤋