Quality, Filmetrics

Quality and Regulatory Compliance

QUALITY AND REGULATORY COMPLIANCE

Each customer’s product requirements and specifications are as unique as the technologies they offer. At VSI, we apply our experience and deep expertise every day in order to meet the often exceptional needs of our customers. With a successful track record in accommodating the rigid standards of highly regulated industries – medical, military-aerospace, and semiconductors – our seasoned quality management system (QMS) is highly capable, robust and versatile.

As part of our ongoing commitment to meeting quality requirements, VSI rigorously complies with the below international and US standards. We are dedicated to maintaining the confidence and trust of customers who rely on us.

ISO 13485:2016 Certified

  • Safety and quality are non-negotiables in the medical devices industry.  ISO 13485 sets out the regulatory requirements for a quality management system specific to the medical devices industry.
  • Download our ISO 13485:2016 Certificate

FDA 21 CFR 820 Compliant

  • Compliance to FDA’s Quality System Regulation (QSR) provides a clear path to go from prototype through clinical trials and into production.  Established best practices help ensure services consistently meet applicable requirements and specifications.

ISO 9001:2015 Certified

ITAR Registered

  • ITAR registration and compliance allows VSI to work closely with companies that provide products that are covered under the United States Munitions List (USML).

Clean Room Coating Facilities

  • Certified ISO class 7 (class 10,000) clean rooms provide a controlled environment where parts can be processed.  The ultra-clean environment effectively minimizes particles to protect parts from contamination.

High level Quality Support

VSI is a full-service solution provider that helps solve problems, eliminate challenges and reduce risk.  As part of our service, we are able to provide quality support that helps get products to market faster and at a lower cost.  Examples of services include:

Process Validations

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

Process Failure, Modes and Effects Analysis (PFMEA)

Root Cause Analysis (RCA)

Gauge Repeatability and Reproducibility (GR&R)