Application Lifecycle Management
Quality Management System
Application Lifecycle Management for medical devices
Our ALM solution helps your team build medical devices with less stress.
Instead of writing big Word documents and trying to maintain Excel files for traceability and risks, MatrixALM allows you to update user and system requirements. Also technical specifications, tests, test results, risks and everything else you need to document for your design, can be created in an agile way.
Let your whole team participate and benefit from up-to-date documentation!
MatrixALM allows you to define any number of layers of requirements, which define the design input and output.
It helps in verifying that the traceability is correct and complete within the whole design development.
The Risk Module allows you to design forms to enter the risks you need to document according to ISO14971. You can customize the forms and formulas according to your procedures and hazard analysis.
Risk controls directly act as design input.
Verification and validation tests can be defined for any layer of requirements. Test scripts can include other tests and run external tools to collect automated test results.
If a test step fails it can be linked to any external ticketing system like JIRA.
From the database stored design input and output you can create documents which render the data as you need it. It can dynamically include anything from simple requirements to complex trace tables.
Documents can be electronically signed whenever you reach a milestone with your medical device.
No two medical device projects are the same, so we make it easy to add layers, input fields and traceability rules. See the list of features for more details.
Quality Management System for medical devices
Our QMS solution helps your team build a great quality system.
The key difference is that MatrixQMS provides realtime tools to bridge the gap between the team and the quality department.
MatrixQMS allows you to add your own specific standards besides ISO13485, ISO27001 and others, which come with the system.
These make it easier to develop your processes and create a gap analysis against the regulatory standards for medical devices.
In this section you define all required processes directly linked to the requirements in the standards. Keep them small and simple so that you and the auditor can understand them.
If you are just starting to build your quality system you can kickstart it with our library of typically required processes.
When you use ISO 13485:2016 you now need to do a risk analysis for your processes.
This is easy, fast and efficiently achieved with the integrated Risk Module.
Work Instructions is the place where are all your technical details for a process are recorded.
These can be updated quickly to keep everything and everyone working effectively.
An integrated CAPA project allows you to log corrective and preventive actions and link them to the tasks in your issue tracking software.
Matrix will take care of the traceability in your QMS and automatically build an audit log with each change for quality control.
A rigorous review process is integrated in MatrixQMS, to ensure no procedure or work instruction is published unless it's been approved.
When all the processes are approved, the QMS can be published to the team to make it easily accessible for everyone.
The published view is streamlined to allow anyone in the company to find the procedures and work instructions that (s)he needs to use.