Quality Assurance

Avenue’s moulds and injection-moulded products are used primarily in medical devices and drug delivery devices where failure would have significant impacts on patients. With our company-wide commitment to lean Six Sigma and continuous improvement, we believe in never-ending improvement to constantly make our processes better and more efficient.

We employ both Black Belt and Green Belt personnel to support our Six Sigma commitment and culture. To certify that all moulds, components, kits, and assemblies are manufactured to exact, agreed-upon specifications, all processes are assessed for feasibility and risk in accordance with customer-specific requirements governing IQ, OQ, PQ (APQP) directives, and are validated and approved by our customers prior to any product being shipped from Avenue. As a result, we consistently achieve Six Sigma levels of quality.

All products are manufactured in compliance with current GMP requirements laid down by the FDA Code of Federal Regulations 21 CFR820 and European GMPs ISO 13485 and ISO 9001. Our operating philosophy is one of continuous improvement and all employees direct their efforts towards ensuring the Quality Management System is effective and operates in full compliance with the requirements of I.S. EN ISO 13485:2016.

Avenue’s ability to achieve all activities in-house in a strictly controlled environment (Class 8 cleanroom) ensures our customers get their products to market faster and with complete confidence.

Quality Registrations:

ISO 9001

ISO 13485 

ISO/IATF 16949 

FDA Registered (since 1979)

Customs-Trade Partnership Against Terrorism (C-TPAT) Compliant