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Quality Assurance

“We as employees of Avalign are committed to meeting or exceeding all customer requirements through the adherence to continual improvement principals coupled with the deployment of a robust Quality System.”

Some of the key strategies we feel are critical to driving continuous improvement are;

Customer Focus – Ensuring that we maintain Quality Systems which meet all customer requirements.  We understand it is our responsibility to consistently deliver quality product to our customers, while operating a robust Quality System.  The Avalign Quality System is designed to comply with all appropriate US/International regulatory requirements coupled with the specific quality system specifications of our OEM customers.

Quality is not negotiable – This is something we train and communicate daily to our employees.  Quality objectives must be met without exception.  Quality is not limited to our operators who touch the product; it is part of everyone’s job.  We are continuously educating our employees that each of us plays an important role in ensuring our products always meet our customer requirements.

Measurement - We are committed to maintaining a Quality System which is consistent and standardized across all sites.  A key method of maintaining adequate oversight of the Avalign Quality System is the routine use of performance metrics. 

Some of the tools we utilize are;

Metrics and Communication – Avalign has established key quality indicators which are shared and communicated throughout all levels of the organization.  Meetings are routinely held throughout the company to review and discuss performance trends and monitor action plans where appropriate.

Statistical Methodology Tools – Avalign utilizes statistics to evaluate and monitor all key process outputs.  Our goal is to ensure all delivered product and services consistently meet customer specifications.

Quality System Software – Avalign has invested in Master Control™ as our Quality system solution to ensure that we are properly and consistently managing and executing all key processes i.e., CAPA, Complaint Investigation, Change Control, etc.

Technical Competence – Avalign has made significant investment in people and tools to ensure that we have the right people and processes necessary to meet our customer requirements.  For example;

Avalign has continuously invested in "state-of-the-art" inspection equipment to ensure that critical design features are met and measured accurately and efficiently.

Quality Engineers are available at each business unit to support "design for manufacturability" activities, risk mitigation (FMEA), validation, control plans, inspection requirements, etc.

Regulatory Affairs

Avalign Technologies regulatory affairs teams has over 15 years experience in managing a broad spectrum of regulatory submissions/approvals including clinical, design, process and sterilization validations.  We have resources available at both our US and European locations which can provide customers with regulatory assistance in both the design and development processes.    

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