NCA receives ISO 13485:2016 Medical Device Certification

GARLAND, TEXAS – May 2021 – NCA receives ISO 13485:2016 Medical Device Certification

NCA — a design, manufacturing and sourcing company in Garland, TX — is proud to announce that it is ISO 13485:2016 medical device certified by BSI. With this certification, NCA can now begin production on the projects it had lined up awaiting ISO approval.

ISO 13485:2016 specifies requirements for a quality management system where an organization demonstrates its ability to provide medical devices and related services that consistently meet customer demands and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation or servicing of medical devices along with the design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be applied to suppliers or external parties that provide products, including quality management system-related services to such organizations.

“We are excited to delve into the medical device industry and see what opportunities this certification presents to us,” NCA President Stephen Lehocky said. “Gaining this certification is just further proof that NCA is dedicated to creating the highest quality products for our partners.” 

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size or type, except where explicitly stated. All requirements specified, in regards to medical devices, apply equally to every associated service as supplied by the organization.

NCA is a family-owned business founded by hard work, perseverance, entrepreneurial spirit and the desire to help the surrounding company. With the ISO 13485, AS9100D and ISO 9001:2015 certifications, NCA is now better able to service its partners and reach a broader variety of people with the products NCA manufactures and designs.