Quality
Assurance & Regulatory Compliance

Producing competitive products for today’s marketplace often requires the help of outside partners. As new technologies are continually developed, it is ultimately strict compliance to standards that guarantees these innovations make it to market. VSI’s quality management system supports customers through this process by providing complete transparency in meeting all regulatory and customer requirements. 

Below are certifications and standards with which VSI complies:

Quality Assurance
& Regulatory Compliance

Producing competitive products for today’s marketplace often requires the help of outside partners. As new technologies are continually developed, it is ultimately strict compliance to standards that guarantees these innovations make it to market. VSI’s quality management system supports customers through this process by providing complete transparency in meeting all regulatory and customer requirements.

Below are certifications and standards with which VSI complies:

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 unique needs of 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

ISO 9001 certification ensures an organization’s quality management system has consistent, repeatable processes in place in order to provide services that meet customer and regulatory requirements.
Download our ISO 9001:2015 Certificate

ITAR
COMPLIANT

ITAR compliance allows organizations 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 (10,000 class) clean rooms provide a controlled environment where parts can be processed. Cleanroom environments effectively minimize particulates 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.

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)

Speak with a Parylene Expert

Whatever your question or concern, one of VSi’s Parylene experts will be able to help you find the answers you need.

Speak with a Parylene Expert

Whatever your question or concern, one of VSi’s Parylene experts will be able to help you find the answers you need.