Design Control

The main features of any medical equipment must be safety, both for who ever is going to depend on the equipment for their life, also for the safe operation in a potentially hazardous environment Eg: an oxygen rich atmosphere or anaesthetic gases may be involved.

In the case of electrical apparatus monitors, and things such resuss equipment electrical safety for the patient (We don't want to kill them) must be paramount.

Isolation and or battery operation should be thought of. Then the EMC factors come into play. Mobile phones are always a potential problem, emergency radios, can be a hazard. The equipment must be robust, not be open to misuse. Have a good overall temperature rating and fail safe. These are some of the many considerations to be taken into account when attempting any design. It must be safe under all known conditions. It must not kill any one. It must not cause an explosion. It must be simple to use. It must work if the power fails (lighting or life support). Etc, Etc.

Not sure of your location, so cant' presume that you are north american. if you are working to FDA GMP (good manufacturing practices) FDA 21 CFR 820. 30 (ithink?), CSA, The various European Medical Device directives , or if you are familiar with former ISO9001 (See 4.4 Old ISO 9001, not new TS 9000.)

Google any of the above and you should get plenty of info and titles of books covering this topic.

If your company is certified to any of the above, then your auditor will tell you if you are following your standards. your standards have to reflect what you do, as well as what is required to assure compliance.

There is a company that I saw at last years medical show in Los Angeles called FOI teleconferences that is always sending me emails on this subject.

US FDA is requiring lots more data submissions in specialized electronic formats, so prepare to get an extensive education on this topic.

After you get design control, you still have many other document and batch control protocols to mull over to get GMP certification.

milo

I always thought the "design V" started at the top on both sides, where the sides could be labelled "suggested" and "expected". as each iteration of the design cycle is completed, the two should become closer until there is an expected result/product which can be produced.

Our main control is the strength of the laughter as you present your design to the management.

If your asking about other industries, no we don't have any constraints as to how to design our product.

My current company has a policy I must follow, but there are no industry rules per say. Here's a quick outline without me disclosing our policy and me to disciplinary action.

First, we get our direction for marketing, I may be able to design it, but if they can't sell it, the company looses.

Second, it MUST perform as required, test it, then test it, then test it some more, when your done with that, test it another way. If anytime your design fails, your not done, you have keep testing it until you can repeat the failure at will, then you know what to fix. Then think of how it can be miss-used and test it for that.

Third, don't expose the company to warranty/legal/safety issues, if in doubt, see the second step.

And lastly, make it cheap, if it has 100,000 moving parts, they still want to sell it for under a $1.

oh, did I forget, they give you a schedule to meet, usually it's based on when the next trade show is...

( the up side, in my business, there is no government approval needed.)

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