NCA earned its ISO 13485:2016 Medical Device Certification earlier this year. This marks a huge milestone in our journey to provide high-quality services and products to our partners. Our quality team came together to ensure our team exceeded the standards set by the certification. Our medical manufacturing capabilities are about to grow greatly!
According to the International Organization for Standardization, “ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
What does NCA earning this certification mean for the medical manufacturing work we’re doing now and will do in the future?
Before earning the certification, NCA assembled printed circuit boards used by medical device companies that save lives in the field every single day. These devices ranged from baby monitors in hospitals to portable ventilators used by first responders across the country. Our partners were creating life-saving products.
Now, NCA can take the next step by designing, manufacturing and assembling life-saving products ourselves. We can take your product from start to finish using our New Product Introduction (NPI), dedicated SMT lines and talented operators. Similarly, we can better serve our existing customers.
What does this mean for you as an NCA partner?
You can rest easy at night knowing your product is in good hands. You’ll receive a high-quality product every time.
Our entire quality control team has been trained and cross-trained to recognize and incorporate the proper standards for this certification. Our quality engineers are working diligently on every project to ensure you don’t have a problem with any NCA products.
Similarly, our existing medical partners now have new opportunities to get more from NCA.
Does this mean my product will take longer to go through QC and testing?
No! Fortunately, NCA’s talented team members are trained to keep your standards in mind. In the same way that our aerospace and defense partners don’t see longer lead times despite the AS9100D requirements, NCA will keep your product moving along at a pace that works for you.
In addition, being a U.S.-based, local partner means you’ll never have to worry about overseas shipping costs or waits.
So what’s coming next from NCA?
Since earning the certification, we’ve added several medical device manufacturing partners and look forward to expanding our capabilities. The past two years have shown just how important this industry’s products and supply chain are, and NCA couldn’t be more thrilled about the timing of this expansion.
We’re constantly improving our processes and our quality standards and are already working towards our next certification! Make sure to stay up-to-date with NCA to learn how we can help you change the world!