Ready to Use Solutions to Manage Medical Device Quality, Compliance, and Regulatory Submissions

THE CHALLENGE

The need for
operational efficiency

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.

Connecting disparate processes

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.

THE DOT DIFFERENCE

Connected quality and regulatory enforcement

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.

Quality and compliance enforcement across the entire supply chain

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.

Reduce time to market with end-to-end visibility

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.

HELPS ENSURE COMPLIANCE WITH THE FOLLOWING REGULATION

  • ISO 9001
  • ISO 13485
  • EU MDR
  • MD SAP
  • ISO 27001
  • ISO 14971
  • 21 CFR Part 820
  • 21 CFR Part 11
  • EU Annex 11
WHY DOT

Pre-Configured and ready to use

Out of the box

Designed for medical device companies, choose from a wide range of ready to use processes and deploy quickly.

Grow with you

The Dot Compliance QMS is designed to grow with you and to minimize your capital investment.

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Friendly system

Increase collaboration and your company’s quality culture with a friendly quality management system that allows you to run on auto-pilot.

FEATURED SUCCESS STORY

You are in good company.

Best-in-class medical devices companies around the world trust Dot with their QMS

Great QMS complaint solution for medical device firms. … one of the best investments out there

Guy Sadhe, CIO

Insightec

Experience ready to use QMS

Find the Dot Compliance Solution for you

Addressing any eQMS need, for any size company with unmatched breadth and depth process coverage

QMS Xpress Symbol

QMS Xpress

Set your eQMS foundation with a comprehensive set of ready to use core quality processes

Xpand

Compliance Xpand

Build upon core eQMS, expanding into other manufacturing quality and compliance specialty areas

Xact

Enterprise Xact

Tailored eQMS, with customized and configured quality and compliance processes based on your unique requirements