|
At TriVirix, we understand
that in our customers’ highly regulated
industries, it is not enough to have a great product
idea. Our customers require superior quality performance
and solid regulatory compliance.
Our quality system is verified by external
audits. TThe TriVirix facility is routinely audited
by the FDA and other compliance certification
organizations and have met each and every past
audit with success.
Of course, the strongest validation is the success
of our customers. The TriVirix quality system
preserves
our customers’ reputation with their own
customers.
TriVirix Quality system features:
|
• |
ISO 9001 / 13485 certified |
|
• |
FDA registered and QSR
compliant |
|
• |
Manufacturing FDA Class II
and III devices |
|
• |
Use of Six Sigma methodologies |
Our customers benefit from:
|
• |
Effective configuration
management guaranteeing that every device
is built exactly according to your specifications |
|
• |
Complete traceability in the
change control system |
|
• |
Thorough record-keeping to
minimize unexpected costs of changes and impact
on products, inventory, and processes |
|
• |
Device history records, capturing
all pertinent information on every device
we build |
|
• |
Strict standards and procedures
to ensure that your product will always meet
agency approval |
|
