Quality

Never ending improvements

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.

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.

Production quality

Six Sigma levels of quality

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.

Quality requirements

Effective quality management system

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.

Certifications

Certified environmental management systems are an important component of Avenues's sustainability work.

Cleanroom production

Controlled production environments

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.

Medical excellence

Creating world-class operations

Medical Excellence is the Nolato groups way of creating world class operations inspired by the Nolato spirit, our strategies, quality standards and our lean processes and tools. Together, these elements create a framework for managing resources efficiently and increasing value for our customers.

Medical Excellence serves as a guide for all employees in the Nolato group. Our objective is to supply quality products and services on time and with minimal waste. By surpassing customer expectations, we can ensure continued excellence and a long-term competitive edge for us and our customers.