Quality Statement

Quality Assurance VLV Associates, Inc. is committed to understanding and meeting the quality requirements of our customer products. I and VLV Associates, Inc. personally affirm this commitment and have established a quality management system to meet the requirements of FDA Quality System Regulation - (QSR's) and ISO 13485 quality standards. We are committed to a continuous quality improvement program. These efforts will enable us to:

Maintain our reputation for Integrity, Quality and Service in the Medical Device Industry.

Continue our Research and Development of new products utilizing our knowledge of Quality System Regulations and ISO 13485 quality standards.

All personnel at VLV Associates, Inc. adhere to the spirit and intent of the firm's quality policy, as well as the directives stated in our Quality Assurance Manual and its supporting quality system documentation.
Michael J. Vaillancourt

Testing Equipment

  • Tinius Olsen Tensile Tester
  • TM Electronics Pressure Decay Tester
  • TM Electronics Package Integrity Burst Tester
  • VLV Vacuum Leak Tester
  • Angiomat 6000 Power Injector


SGS Certification ISO 13485:2003 VLV Associates, Inc. is an FDA registered facility and adheres to the FDA guidelines following 21 CFR 820, cGMP's (Current Good Manufacturing Practice) and the Worldwide QSR's (Quality System Regulations).

VLV Associates, Inc. is an ISO 13485:2003 certified facility for Medical Devices and Quality Management Systems. Click here to view our certificate.

Celebrating 30 Years!