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Showing posts from February, 2015

Regulations on medical software development kill more than save

After a two years as a sw testing specialist in the medical device industry, I decided to quit my job. Reasons were many, but perhaps the biggest one is the insane situation where regulations have taken the industry. As a summary, I have come under the belief that these regulations kill more people than save. This is because of: - the unbelievable opportunity cost - the delay in time to market - killing of innovation - restricting of competition and because of the fact that regardless of all those regulations, you still can fake it all. Actually it is easier to fake than follow. The main idea in the regulations is that everything needs to be planned in detail, executed accordingly, and documented to be done this way. And by planned in detail, they mean that there needs to be a documented plan, in which all the actions taken needs to be specified. If you do something that was not in the plan, you are in trouble. If you don't do something that was in the plan - boy are yo