Quality Policy Statement

Quality Assurance VLV Associates, Inc. is committed to understanding and meeting the quality requirements of our customer products. I, Michael Vaillancourt 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), ISO 13485 quality standards, MHLW Ministerial Ordinance No. 169, and MDD 93/42/EEC requirements. 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 the Quality System Regulations, ISO 13485, MHLW Ministerial Ordinance No. 169, and MDD 93/42/EEC requirements.

All personnel at VLV Associates, Inc. adhere to the spirit and intent of the firm’s quality policy, as well as the directives of the 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


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).

Celebrating 30 Years!