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Quality Management Systems-

Surgical Technology Laboratories/DBA Surgiform is a FDA registered medical device establishment (Establishment # 1825527) operating in compliance with 21 CFR 820 (current Good Manufacturing Practices) and ISO13485:2016 (Medical Device – Quality Management Systems).

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 operate in accordance with current 21 CFR Part 820 Quality System Regulations and compliance with ISO 13485:2016.

 

Links to Registrations and Certifications –

 

 FDA 

 

   Certification