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Planning for verification and validation

Posted: 24 Sep 2015     Print Version  Bookmark and Share

Keywords:Design verification  validation  life cycle  risk assessment  battery 

We are all familiar to Russian nesting dolls, each perfectly decorated doll giving way to a smaller one inside. Every one of those little dolls, even the impossibly tiny one at the centre, is hand turned, carefully decorated and finished with a fine gloss.

Medical device design operates on a similar concept, layering smaller components together to form one machine, each component tailored to the needs of the original equipment manufacturer (OEM).

Design verification and validation are akin to the finishing gloss, and aren't reserved for the largest doll—or completed product; each component gets the same gloss

The words verification and validation are a little overused, and it can be easy to confuse the two processes or even to think they are one and the same. However, they are distinct and important practices that OEMs can't afford to take for granted, especially in the field of medical device manufacture. The possible repercussions of failing to ensure that your new device is effective, safe and fit-for-purpose in medical and healthcare applications can be severe.

So what's the difference between the two? Design verification establishes whether you designed the device right to the specification, design validation ascertains whether you designed the right device to meet customer expectations and requirements. The distinction may be subtle, but it is significant.

There's no room for error when supplying medical devices, so verifying and validating your design proves that you've developed the best possible solution to a specific need and that it is safe to use. However, did you know that OEMs designing the machine are not the only ones going through this process? Often, the smaller components within a device are bespoke designs created by another OEM, such as the all important battery.

At Accutronics we understand how important it is to design the right batteries for our customers that are both effective and safe. That's why the team places such a high premium on the two Vs. Not only does this prove our own products are up to scratch, it helps OEMs using our batteries to verify and validate their own devices.

Plan for success
Much like lining up your Russian nesting dolls in height order before tucking them away, successful design validation and verification requires order and planning. Treating this process as an afterthought will, at best, cause you a headache, at worst it could mean your device fails the procedure.

When we first sit with any customer to establish a brief for battery design we set up both a design verification plan and a design validation plan. These documents, which are reviewed regularly throughout development, mean we stay on target and develop the very best product for our clients' needs.

A design validation plan should include a validation strategy that covers life cycle and risk assessment, validation deliverables including design specification, operational support, and continuity plans, acceptance criteria; standard operating procedure, training, documentation management, and guidelines on maintaining the validated state.

By comparison, a design verification plan should describe in detail the tests and trials that the device needs to be put through.

Testing the waters
For medical devices to pass validation and verification, they have to be built in the long term production environment as well as put through testing—in other words on the production line and by the people that will actually manufacture the product.

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