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.


TÜV SÜD
Michael J. Vaillancourt
President


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

Regulatory

TÜV SÜD Certification ISO 13485:2016 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 13485:2016 certified facility for Medical Devices and Quality Management Systems. Click here to view our certificate.

VLV Associates also has our EC Certificate for Medical Devices Directive 93/42/EEC, Annex II excluding (4) and our Registration Certificate of Foreign Medical Device Manufacturer for Japan.

Celebrating 30 Years!