ATS offers Quality Management products and services for medical device manufacturers. By combining Smart Digital Transformation with the solid principles of Manufacturing Execution Systems (MES) / Manufacturing Operations Management (MOM), Scanning and Dimensional Services, Quality Management Systems, Lean Manufacturing, Six Sigma and Total Productive Maintenance we ensure you achieve ISO 13485 compliance every step of the way.

Software Solutions for Total Quality Management

Our in-house software solutions enable you to monitor and improve your medical device quality. Whether it’s dimensional, attribute, variable or operation, we can bring your data together to give you a complete picture.

The results of visual inspections can be recorded digitally, with quality issues being recorded directly onto a CAD model of your product. This provides you with a digital thread all the way through your manufacturing processes and removes paper forms with all of their deficiencies.

By connecting to your factory floor equipment our software will also collect data directly from test equipment and CMM machines. And if you’re utilising cameras in your inspection, we’ll send that data to the cloud for some AI analysis so that dimensional and attribute issues can be automatically highlighted.

With all your quality information being recorded directly into the system (with no transcription delays and errors) your quality data is available for reporting and analysis in real-time. And should an audit occur you can be sure that you can prove your ISO 13485 compliance with ease.

To see how effective our quality software solutions can be, please download the Trulife case study at the top of this page.

A Complete Quality Management Service

Beyond our software solutions, ATS also provides medical device manufacturers with the knowledge, training and support they need to improve quality throughout the production process.

ATS follows a structured work package method to ensure successful implementation, by means of strategic and tactical advice to medical device manufacturers on Quality Management.

When we partner with a company, we ensure that they achieve the highest possible quality in the most cost-effective manner, providing them with a number of benefits:

  • Root causes of problems readily identified allowing corrective measures to be implemented.
  • Repeatable, defined procedures for quality management activities.
  • Responsibilities and formal line of escalation are managed digitally.
  • Dynamic scheduling of resources affecting quality tasks.
  • Automatically managed quality issues.
  • Constant monitoring of critical variance metrics.
  • Ensure ISO 13485 compliance is built into your processes.
  • Methods, documents and procedures for quality control activities supported throughout product lifecycle.