ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION?

[vinothkumarp]

Hello All,

We are a small scale Medical Device company with the valid ISO 13485 Certification.

We are planning to launch a new medical device, that will be re-designed for our existing model and will be sold in the market in the new model name.

Our Query is: We got the certification by compiling the QMS process that was included with our first Medical Device "ABC", now we will alter the aesthetic and will increase product outer size, where, there will be NO change in the functional specifications. And, the same will be released to the market like a new Medical Device "ABC-1".

In this case, do we need to apply for new certification? Or do we need to call for any audit before to the Surveillance/ Recertification Audit, that needs to happen before with our product launch into the market?

Any Advice?

Thanks in Advance.

#ISO13485 #Audit #Auditquery #NewproductAddition

 

[indubioush]

And, the same will be released to the market like a new Medical Device "ABC-1".

Which market?

 

[Junn1992]

I don't see why you would need a ISO 13485 re-certification if your product scope does not change. You would need to be re-certified if, for example you will sterilize a product which was previously un-sterilized. If the scope of application of ISO 13485 does not change with the new product, no re-certification is required.

This is because ISO 13485 covers product realization, from planning phase all the way up till post market. As long as those processes are in place proper, and documentation is properly done, you will have no problem during the ISO audit.

You may however, be audited by the medical device regulatory authority, such as NB's if you require a CE certificate for new product.

 

[somashekar]

We got the certification by compiling the QMS process that was included with our first Medical Device "ABC", now we will alter the aesthetic and will increase product outer size, where, there will be NO change in the functional specifications. And, the same will be released to the market like a new Medical Device "ABC-1".

It looks like the new device is in line with your scope of the ISO13485:2016 certificate. Apply your design and development controls to the new product ABC-1. Ensure that the Clause 5.4.2 requirements are well understood and implemented at all stages of product realization. Inform your CB as this is a significant change. Your CB may ask more questions and send you a clinet information format to update the information. The survelliance audit should then cover your ABC-1 related QMS implementation as well, and your certificate gets maintained.

 

[vinothkumarp]

Europe and India Market

Which market?