QUALITY

Spectra Medical Devices, LLC Quality Commitment:

  • Provide safe and effective products that satisfy our customer’s needs​
  • Maintain Product Quality and Safety “built in” and not “tested in”​
  • Continually review and improve the effectiveness of the QMS​
  • Ensure compliance to all applicable regulations​
  • We deliver this through aligned objectives, teamwork and open communication​

fda registration #:
1224960

MASSACHUSETTS, U.S.A.
Cert # 0124793​
Expiration 5 Jun 2025​

SOUTH KOREA
Cert# SCC-0074-6​
Expiration 28 Feb 2025​

US & Korea Sites are 13485 ISO Certified​
Spectra Medical Operates a Class 8 Clean Room