ISO 13485 Registered

Quality Assurance & Regulatory Affairs

Quality

Our primary quality objective is to meet or exceed our customer requirements. To achieve this goal we have established a quality system in accordance with QSR and ISO 13485:2012 requirements. Our quality infrastructure includes a staff of Quality Engineers assigned to development, manufacturing and service responsibilities as well as a Document Control Department responsible for the release and maintenance of quality records.

Key features of the Stellartech Quality System are:

  • Extensive product design validation and verification testing
  • Manufacturing in strict accordance with approved device master records
  • Thorough inspection and testing of each medical device before release
  • QSR/ISO 13485:2012 quality system for the design and manufacturing of Class II and Class III medical devices

  •    Stellartech has:

    • FDA establishment registration
    • ISO 13485:2012 quality system certification
    • CE Mark for HF surgical devices and catheters
    • State of California Medical Device Manufacturing License
    • TUV IEC 60601 safety certifications
    • UL, ETL, CSA safety licenses

Regulatory and Quality Assurance

Stellartech offers depth of experience in medical device regulatory submissions and regulatory compliance. We have a record of success in satisfying FDA requirements for 510(k) submissions and in working with TUV USA for IEC 60601 safety certifications and UL 60601 safety listings. We also have obtained numerous UL, ETL, and CSA safety licenses for our customers.

We offer a number of services upon request, including assistance in:

  • Development of regulatory strategies
  • Preparation of 510(k), IDE,  PMA, and CE submissions
  • Obtaining IEC 60601 safety certifications and CE marks
  • Obtaining UL, ETL and CSA licenses
  • Performing and managing type testing to IEC 601 and other standards
  • The development and validation of sterilization cycles

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