“Recently there was an urgent call from an Engineering Program Manager based in Jacksonville. They are one of the TOP 10 Med Tech Company planning to introduce their new product in South East Asia region.
I asked him “You have a separate Regulatory and Quality group handling Asian Market. Why can’t you go through your own people?”
Here comes the cryptic reply “Yes, it takes a long time to get through our own internal processes. It would be easier to work with the partners for the timely execution”.
This customer saw an immediate opportunity in this region and was looking for someone to help them to put the regulatory approval process on fast track. “The product design should also be modified to meet the country specific user requirements”.
We were on board quickly, started understanding the current design, executed engineering changes to meet the additional requirements, got through the design qualification process and wow, this customer is now ready to launch the product!
We understand the product domain and have knowledge of the regulatory requirements of any region which would be the key drivers for the success of your program.”
2 Comments
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