Get products into production and revenue more quickly
Time to market is a key element in many medical device manufacturers’ strategies. There are critical points at which we help to accelerate it.
Quickly characterize processes during product development
Our technology helps development groups to quickly understand their manufacturing proceeses to get new products to market more quickly. The tools help to identify and control process variation, provide proof that the automation processes are under control as well as evidence that new equipment is operating the same as existing, validated equipment. This is all done using objective and traceable data.
One cardiac device manufacturer was able to get a product into full production in 3 months instead of 8
Reduce validation time
Validation is typically a painful part of the process and we help to reduce the time to do it. We provide documented 21 CFR Part 11 support on all products and 90% of validation is common across line-wide deployments. We provide validation test plans specific to support your validation efforts. Our modern Web-based analytical tools provide full scientific data and credible reports to support PMA and 510(k) submissions.
In short, we provide the insight you need to prove the product is ready to be safely manufactured, with the data to back it up.