Solutions for the Medical Device Industry
The rules for success in Medical Devices leave no time for hesitation, no room for error, and no forgiveness for information voids. In a market where product lifecycles are shrinking and price decay is accelerating, achieving and maintaining competitive advantage means steering innovative products through regulatory scrutiny quickly. Prices must be kept low without compromising quality, and still be capable of generating profits.
ASI DATAMYTE has a proud history of empowering medical device manufacturers to guarantee quality, improve throughput, beat back costs and ensure compliance to standards and regulatory mandates like FDA 21 CFR Part 11. While our SPC solution tightens tolerances and increases yields, our Defect and Rework Tracking solution catches errors quickly and reduces scrap. Integrated Quality Planning and Document Management address compliance needs and keep things focused. Our powerful ►QDA software platform provides decisive control over Complaints and Supply Chains and integrates applications and data flows with Traceability and Validation.
We are always on the vigil for new ways to raise quality in manufacturing, assembly and laboratory operations and ultimately improve your bottom line.
Defect and Rework Tracking
Gage and Tool Management
Integrated Quality Planning
Management and KPI Reporting
Supply Chain Management
Traceability and Lifecycle Management