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.
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.