QMS Software for Medical Device & MedTech Industries
Ensure compliance with the regulation standards and simplify your quality management processes.
Connect all your quality processes
With SimplerQMS you can easily integrate quality management processes with audits, risk management, post-market surveillance, and other processes within your medical device or medtech company.
Quickly upload and hyperlink any document, record, file, and email to quality events, as evidence. With our QMS software for the medical device and medtech industries, you can automate the collection of data, routing, follow-ups, and escalation of overdue activities.
Store everything in a centralized location
With SimplerQMS you won’t have to waste time searching for the required documentation, for example, when compiling your Design History File (DHF), Device Master Record (DMR), and Technical File (TF).
Centralized, cloud-based storage, and integration to other quality processes, allow you to access your documentation and present it to the auditor with a couple of clicks from anywhere in the world.
Save time and ensure regulatory compliance
Utilize tools and functionality for obtaining and maintaining your ISO 13485 certification. SimplerQMS is ISO 13485:2016 certified and offers a ready-to-use solution that helps you assure continuous compliance with FDA 21 CFR Part 11, ISO 13485, 21 CFR Part 820, GAMP5, EU MDR, EU IVDR, and others.
Additionally, we are ready to participate whenever your organization is audited or inspected – and SimplerQMS is also, always open for audits. This means will help you get through your audits seamlessly.
Avoid time-consuming validation processes
SimplerQMS QMS software solution is pre-validated to fulfill the computer system validation requirement of ISO 13485:2016, GxP guidelines, and FDA 21 CFR Part 11.
This means that your organization does not have to spend any time or money on system validation processes.
100% transparent pricing
With SimplerQMS you get everything for one subscription price, depending on the number of licenses.
This means there are NO implementation fees, extra charges for hosting, system validation, user training, ongoing support, or additional modules. It’s that simple.
Access ongoing user support
We provide ongoing support by email, phone, and video calls, which is included in the subscription price.
We take pride in offering high-quality and timely support to our clients and our goal is that you and your colleagues can work in SimplerQMS with as few interruptions as possible.
Secure QMS solution for medical device and medtech organizations
SimplerQMS uses the M-Files Document Management platform as a core of its system. M-Files technology platform serves over 5,000 customers across 100 countries. It is well developed and tested to reach the highest levels of reliability and efficiency.
SimplerQMS uses the highly secure Microsoft Azure Cloud Storage solution. This means that your documents will be stored in the cloud. Therefore, you do not need to invest in highly specialized competencies and expensive server hosting hardware.
We take full regulatory responsibility for your QMS software
We ensure compliance according to the requirements of the following standards, regulations, and guidelines in the medical device and medtech industries.
Compliant digital solution providers
Our technology platform and cloud storage providers, M-Files and Microsoft Azure Cloud, are certified according to the following standards:
- ISO 9001:2015
- ISO 27001:2013
- ISO 27018:2014
The SimplerQMS modules cover all your processes
No matter if your medical device or medtech organization is a start-up or a later stage company, our integrated modules cover your needs. All of the modules are included in the SimplerQMS Subscription.
Save time with automated training activities, learning overview, reminders, and generation of training certificates.
Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.
Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.
Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.
Manage all the necessary processes related to product design and meet design control requirements with ease.
Automate and standardize your document control activities with ease.
Consolidate risk and handle your risk management file in a well-organized and structured manner.
Simplify supplier-related activities and handle your supplier documentation following the standards.
Featured Case Study
From Paper to Digital Workflows in 1 Month
Reapplix is a regenerative medicine company that helps people who suffer from hard to heal diabetic foot ulcers, which may result in amputation. The company is in the initial commercialization phase in the US and selected European markets and was looking for a way to get rid of inefficient paper-based documentation and processes.
Trusted by companies around the world
Ready to learn more?
To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.