Design Verification Vs Design Validation

 

If you develop yourself— medical devices, — then you’veseen the terms design validation and design verification (also referred to as V&V). Here we’ll try to find out  what these 2 activities are , the distinction between them, and share tips for understanding the foremost out of your efforts.

It is clear that when you make any product, you always have user in mind. User can be medical professional or the patient. When you build up product considering design input, so you make design document and you write down all design input. Now next step is one need to check whether design output is matching with design input. This is design verification. This means one need to actually verify the output by using test methods and check quantifiable units whether they are matching with design input parameters.

By simple verification it cannot be judged that product will work the way we have thought and that need to be proved that is design Validation. So even if design verification is successful does not mean that product will behave it is supposed to and that check is conducting performance and that process is Design Validation.

Tips for higher Validation & Verification

Plan Ahead (And take a look at Early)

Right first step first is a good approach.

Design input must come from user need, regulatory requirements, products in market and several such factors with your aim as to why you are developing product.

Involve any experts, use multiple idea through multiple brain, debate and agree and finalise.

Always Use Shared Nomenclature. Means terminology prevalent in documents and not your own.

 

Getting your team on identical page is important. Training to all on relevant topics is therefore very essential.

Build Your Trace Matrix as You Go

Integrate needs Traceability & Testing As you knew that Design verification and Validation brings end to end closure with traceability. Design verification completes major task and validation confirms not only device performance but also all associated tools you use to measure performance.

This does not come so easily multiple teams gets involved and experts and professional brain works behind that. Close link between testers and developer’s constant communication amongst them.

Choose Tools you'll be able to customise to Your methodology

The medical device development tools you opt for ought to augment the accuracy and effectiveness of the work your team is doing, and not add unneeded overhead to their daily tasks. An Efficient tool provides guard rails to confirm that the necessary things required in this area are invariably done. It provides V&V targeted information capture and reportage to create production of reports easy and repeatable.