Quality

Our commitment to quality is built around our ISO 13485 certification and our dedication to exclusively serving the medical device industry. We received our initial registration of device establishment from the FDA in 1988, officially registered in 1989 and continue to comply with all regulations and requirements. Our quality practices and procedures are based on lean manufacturing principles and go beyond industry standards to provide our customers with unparalleled accuracy and unmatched precision. Our dedication to quality serves as the foundation of the company as we strive for excellence in every part we manufacture.


FDA Links:

FDA Registration Number: 1066368

Establishment Listings under this Registration


Our Quality Management System registration certification is to ISO 13485: 2016. We passed, without findings, the upgrarde audit for ISO 13485: 2016. Click on the BSI logo to download a copy of the certificate.

Our Management Team has a proven track record of compliance to risk management requirements to ISO Medical Device Standards and to meet FDA requirements.

Highlights of 2019:

  • Successful re-certification to ISO 13485:2016

  • Successful Micro-biology Audit of our new ISO Class-7 Controlled Environment