Surgiform's Quality Management Systems

Surgical Technology Laboratories, Inc., DBA Surgiform Technology, Ltd., is an FDA-registered medical device establishment operating under a Quality Management System that complies with applicable requirements of 21 CFR Part 820, Quality Management System Regulation (QMSR), and ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes.

Quality Policy -

STL/Surgiform is committed to providing high quality, safe medical products and to maintaining the effectiveness and compliance of our Quality Management System.

  • We will manufacture products in compliance with our established procedures.
  • We will strive to meet or exceed our customers’ expectations.
  • We will seek continuous improvement and will maintain a business environment in which quality and customer satisfaction are the organization’s highest priorities.
  • We maintain our Quality Management System in accordance with applicable requirements of 21 CFR Part 820, Quality Management System Regulation (QMSR), and ISO 13485:2016.

 

Links to Registrations and Certifications –

 

Surgiform ISO Certification