Reading time ( words)
Naprotek, Inc. has successfully renewed its ISO 13485:2016 certification. With the recertification, Naprotek is equipped to serve the medical device industry with a proven quality management system.
“Naprotek has been the high reliability EMS provider in Silicon Valley for 24 years,” stated Jayne Carthy, Director of Strategic Business Development. “Our customers depend on us, and we take great pride in our quality and service. PERIOD! Our ISO 13485 is a certification that we take very seriously as more than 25 percent of our annual revenue is driven from the MedTech industry. As we continue to grow, this will remain a cornerstone of our business.”
The ISO 13485 standard supplements the ISO 9001 standard and is specific to medical device quality systems. ISO 13485:2012 was published in January 2012 and supersedes ISO 13485:2003. The new version of the standard was developed to harmonize with the EU Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC. It provides assurance to medical device end-users outside of the United States and assurance of compliance to the European legislation.
Naprotek’s medical capabilities include:
- Ability to support the product’s full lifecycle from NPI through end-of-life
- IPC–A-600, IPC-A-610 and J-STD-001 certified operators
- S-2020 compliant
- Automated first article inspection/verification process
- Inspection capabilities which include automated optical inspection (AOI) and X-ray
- Automated cleaning capability and a track record of supporting PCBA cleanliness requirements which meet or exceed IPC J-STD-001 current rev
- Customized quality reporting, device history recordkeeping, traceability to the component level
- Counterfeit component mitigation program in place
- Ability to support hybrid leaded/unleaded component mix on products
In addition to its ISO 13485:2016 certification, Naprotek is certified to ISO 9001:2015, IPC-A-610, IPC-J-STD-001, IPC-7711/7721, AS 9100 and ITAR registered.
Naprotek sets the standard for high-quality prototypes and Made-in-America production. The company specializes in mission critical products, and its processes and systems are focused on delivering award-winning quality.
About Naprotek Inc.
Founded in 1995 by entrepreneur Najat El-Ayi Badriyeh, Naprotek has provided electronic manufacturing services to startups and OEMs in Silicon Valley and throughout the US. Naprotek evolved from a consigned-assembly business to a full-suite service provider for printed circuit assemblies and box-build. Naprotek’s track record continues to benchmark quality, service and cost-effective solutions for its customers. The company has a strong footprint in the military and aerospace markets with its AS 9100 Certification, as well as the medical market with its ISO 13485 Certification. For more information about Naprotek, visit www.naprotek.com.