Provider of electronic manufacturing services, Naprotek, has announced that it 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,” said Jayne Carthy, Director of Strategic Business Development. “Our customers depend on us, and we take great pride in our quality and service. Our ISO 13485 is a certification that we take very seriously as more than 25% 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.