Medical Device Development, Design and Software
What Does ISO 13485 Certification Mean to Our Customers?
ISO 13485 is an internationally recognized quality standard for the design, development, production, and sale of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
In addition to approving SterlingTech's quality system and practices, ISO 13485 Certification allows our clients to streamline their auditing process when selecting a medical device partner.
Whether a start-up or a seasoned developer, SterlingTech clients can be assured that all of our development and testing processes, our equipment, and its calibration are consistent with ISO.
We use an independent auditor who audits directly to the standard. Therefore, due diligence is automatically performed at every phase of the process. Start-ups can rely on our certification while they are in the process of achieving their own.
ISO certification positively affects our processes in every area.
- Software and Hardware
- Development and Testing
- Shipping and receiving
- Contracts
- Management
- Supervision
- Training
- Documentation Control
SterlingTech maintains a partner-level commitment to every client relationship. ISO certification represents yet another important step in that partnership.