Compliance Consultants has worked on various
catheters, cannuals, flexible bag systems, and
other similar components that are integrated into a
sterile tubing sets.
Compliance Consultants was asked to intervene and rescue a failed tubing set to support clinical trials. The tubing Set had a metered pump to act as a conduit where blood is taken from a patient, delivered to a therapeutic instrument and returned to the patient to achieve a clinical benefit. Compliance Consultants conceived, designed, acquired parts, assembled a proof of concept, fabricated and tested a remedial version in 7 days. We then tested and sterilized a limited run. Compliance Consultants built and supported the first 60 units for this clinical trial. These had an excellent reputation for reliability. These actions were part of the 510(k) application.
Compliance Consultants was asked to intervene and rescue a failed tubing set to support clinical trials. The tubing Set had a metered pump to act as a conduit where blood is taken from a patient, delivered to a therapeutic instrument and returned to the patient to achieve a clinical benefit. Compliance Consultants conceived, designed, acquired parts, assembled a proof of concept, fabricated and tested a remedial version in 7 days. We then tested and sterilized a limited run. Compliance Consultants built and supported the first 60 units for this clinical trial. These had an excellent reputation for reliability. These actions were part of the 510(k) application.
Tubing Sets for phlebotomy / venepunture to collect blood, Single-Use Connectors, Flexible Bag Systems, Tube Assemblies & Bioprocess Equipment, Disposable Blood Tubing Sets, Hemodialysis Blood Tubing Set, Introducer Needles, Cardiothoracic & vascular surgery, general medical disposable products, 21 CFR 880.5570, Product Code FMI, 21 CFR 880.5570, Product Code FMI
