Quality/Validation

SMC’s ISO accredited and FDA facilities provide the highest quality standards for your medical device. Our strength in IQ/OQ/PQ and cGMP/QSR compliancy ensure your device meets all of your requirements time and time again. Our commitment to quality has been recognized by some of the largest medical OEM’s. From initial design through final product assembly and packaging, we have stringent systems in place to verify that your device maintains the highest level standards in the industry. With in-house automation we can create systems that perform a 100% verification test of a final product before it is packaged and sterilized, ensuring an optimized manufacturing process.

Our Registrations:

  • ISO 13485 Certified Facilities
  • cGMP/QSR compliant
  • FDA Registered Facilities
  • ISO Class 7 cleanroom environments
  • ISO Class 8 cleanroom environments
  • Japanese Foreign Manufacturers Accreditation Certification