Our expertise in complex electronic and electro-mechanical equipment, attention to detail and deep understanding of government regulations, enables us to offer efficient, cost-effective and high quality products, on time—every time!
The focus within this highly regulated market means a commitment to knowledge and staying ahead of strict regulatory requirements, changes and trends. In addition to maintaining ISO 9001 / ISO13485 certification, FDA registration and QSR compliance, we continuously evaluate and improve our own internal processes, adhering to the principles of Lean Manufacturing and Six Sigma giving you best-in-class manufacturing capabilities.
With this focused expertise, Nortech delivers:
- Cost efficiency with quality – Through a comprehensive supply chain management and a highly-skilled manufacturing team.
- Guaranteed quality – Rigorous test procedures, stringent engineering change control and thorough device history record management ensure high quality. The result – a quality record with 99.6% customer acceptance of production yields.
- Ensured FDA and regulatory compliance – Our experienced team is committed to sustaining high quality outcomes while staying compliant with strict FDA regulations.
- Staying in control – Even though you’ve outsourced your manufacturing, you continue to be an active member of the project team. We provide you with access to real-time production information from inventories to material cost, and from manufacturing instruction to quality records, via AllianceNet, our proprietary, information portal.
Trust Nortech Systems for its Knowhow of Highly Regulated Markets