Medical Device Quality Management System (QMS) – ISO 13485
Never leave quality and safety to their own devices
In this highly regulated industry, where patient lives and brand value are on the line, an advanced QMS for medical devices offers compliance with regulatory standards such as Current Good Manufacturing Practices (GMP), 21 CFR Part 11 and Annex 11 and ISO: 13485, eMDR electronic form submission and more effective system validation.
A Medical Device Quality Management System (QMS) is a framework that ensures compliance while fostering innovation at the speed required to compete on a global scale. It requires streamlined, agile quality processes that quickly close the loop on medical device quality problems.
Big players in the medical device industry recognize the critical need to implement an automated medical device QMS. This system provides a competitive edge through enhanced standardization and a best-practices framework for continuous improvement.
An advanced QMS for medical devices offers compliance with regulatory requirements such as Current Good Manufacturing Practices (GMP), 21 CFR Part 11 and Annex 11, ISO: 13485, eMDR electronic form submission, and more effective system validation.
Supply chains can be opaque but we help you see them clearly
Automated supply chain quality management with ETQ Reliance medical device quality management system helps you monitor and manage suppliers closely to:
Validation for life sciences, pharmaceutical and medical devices companies is not an option. ETQ’s validation solutions make mandatory quality processes fast, efficient and hassle-free. We offer two levels of validation support and services that reduce the time and expense associated with validation.
Self-validation: ETQ provides the ETQ Reliance Validation Execution Package that shows the development, testing and documentation approach for our platform and solutions.
ETQ Validation Consulting Services: ETQ’s team of expert validation consultants will ensure compliance with current regulatory requirements and help you understand our vendor test records and methodology.
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Connected Quality
Eliminate data gaps in product quality
Improve end-product quality, speed new product introduction, make Smart Manufacturing a reality
Bridge the data gap between product quality control (QC) and in-process quality assurance (QA).
Benefits of a Medical Device Quality Management System
01
Document Control
Document Control
Automated workflows
A medical device without proper documentation is an accident (or audit) waiting to happen. An automated document control system can not only organize your documents so that you can find them when you need them; when you change a document tied to a particular product, they can also use automated workflows to make corresponding updates to any related documents.
02
Collaboration
Collaboration
Make collaboration easy
A QMS software for medical devices keeps track of everyone associated with a product — from the vendors who supply the raw materials to the folks who check quality on the plant floor. If there’s a nonconformance, a workflow automation can notify everyone involved that there’s all problem to solve and mitigate. It can get everyone in corrective action mode without wasting valuable time.
Closely integrating customer complaint management with other quality management software functions enables identification and analysis of suspected cause and process failures, informing the need for containment action.
As more and more medical devices are IoT-enabled, a medical device QMS software can monitor the information they generate and initiate proactive responses when there’s a nonconformance.
04
Supplier Management
Supplier Management
Med device supplier management
If a medical device company requires their suppliers to meet certain criteria, the ETQ Reliance QMS for medical devices can provide the platform for entering and updating information about the vendor’s own quality management.
Foster better communication and visibility with suppliers
Increases visibility on both sides and track items that need to be addressed
Improve responsiveness of suppliers, while also streamlining collaboration at every phase of the process
Our mission is to deliver optimal quality that creates benefits for top- and bottom-line financials and global growth. ETQ Reliance medical device QMS gives customer the power to:
Improve Decision Velocity
Improve decision velocity by delivering trusted prescriptive and predictive information using analytics, automation, and AI
Businesses can only solve the problems they know about, which makes customer complaints an invaluable tool in managing risk. In regulated industries, complaints can be an early warning system that an organization may be at risk for regulatory action.
Learn how Avanos implemented an automated medical device quality management system in preparation for Medical Device Single Audit Program (MDSAP) compliance
Like many life sciences and medical device companies, Symmetry Surgical faced several challenges. The company needed to adhere to changing FDA and other regulations while simultaneously protecting its brand value.
But as a small company comprised of four operations sites, 250 employees, and just six quality engineers, it was clear that Symmetry needed a medical device quality management solution that would provide immediate value and was able to grow as the company’s needs evolved.
