Quality & Regulatory
ATEK Medical is an FDA registered medical device contract manufacturer. We comply with the ISO 13485:2003 standards and have been awarded our certificate from TUV. We are also an Accredited Overseas Manufacturer of Medical Devices per Ministry of Health, Labour and Welfare (MHLW, Japan) and we are also IPC-A-610 certified (trainers and inspectors).
Our quality assurance department is comprised of:
- Auditors
- Quality engineers
- Equipment calibration specialists
- Quality assurance inspectors
- Regulatory compliance specialists
- Configuration management specialists
We are dedicated to producing very high quality finished medical devices.
Our Quality Engineers use their cross industry experience with the use of statistical techniques to provide disciplined process and root cause analysis application to the medical device industry.
Quality Policy
Our commitment to quality and maintaining an effective quality management system is reflected in our RESULTS:
Relationships that enable us to meet or exceed customer requirements
Excellence in a quality management system that is customer focused
Service that meets or exceeds customer expectations
Unwavering integrity in dealing with our customers and suppliers
Leadership that clearly communicates goals and expectations
Teamwork that maximizes continuous improvement
Speed to market high quality products
ATEK Medical has a quality culture that has been built on a strong foundation of continuous improvement and lean manufacturing practices.
Our quality system is audited by external parties (regulatory bodies and customers) at least once a month on an average. We look at audits as a source of constructive feedback to help us in our pursuit of continuous improvement.
Equipment, fixtures, and gauges are controlled and maintained through our preventative maintenance and calibration systems. We have developed and continue to maintain a customized calibration system traceable to the National Institute of Standards and Technology.
ATEK Medical has assisted its customers in several 510k submissions, EU submissions, Japanese regulatory submissions, and other international regulatory submissions.