Delivering safe, profitable products on-time, every time while also facing competition, new regulatory requirements, globalization, and increased financial scrutiny is forcing medical device companies to innovate and re-conceptualize even the most elemental business functions.
For best-in-class device manufacturers there is no other option besides deploying cloud based, end-to-end quality management throughout the product value chain. This allows medical device companies to mitigate risks, and create visibility, traceability, and better performance by integrating data from the beginning of the design cycle, manufacturing, and to post-market surveillance.
Automate quality processes while continuously monitoring, tracking, and reporting on regulatory requirements. Dot Compliance ready to use solutions helps you mitigate device manufacturing risks, while ensuring compliance with regulations such as 21 CFR Part 11, 21 CFR Part 820, GMP, ISO13485, ISO9001, and others.
With Dot Compliance QMS solutions, you can manage and automate your entire quality ecosystem within a single source of truth. Promote collaboration, and ensure your organization and outsourced suppliers get the required visibility in real-time from early product development – design history files (DHF) and device master records (DMR), manufacturing – to post-market surveillance.
The key to avoiding uninformed and untimely decisions is by getting the right data in the right decision-maker’s hands at the right time with integrated data through the entire product lifecycle. Medical device manufacturers rely on Dot Compliance for all core quality assurance processes, training, regulatory compliance, and document control.
Designed for medical device companies, choose from a wide range of ready to use processes and deploy quickly.
The Dot Compliance QMS is designed to grow with you and to minimize your capital investment.
Increase collaboration and your company’s quality culture with a friendly quality management system that allows you to run on auto-pilot.
Great QMS complaint solution for medical device firms. … one of the best investments out there
Addressing any eQMS need, for any size company with unmatched breadth and depth process coverage
Set your eQMS foundation with a comprehensive set of ready to use core quality processes
Build upon core eQMS, expanding into other manufacturing quality and compliance specialty areas
Tailored eQMS, with customized and configured quality and compliance processes based on your unique requirements