Digital Quality Management System
for medical device manufacturers
Training, infrastructure, purchasing and CAPA in one platform. Every case has a status, a deadline and a responsible person, and its history is recorded. NexiMed AI prepares proposals – decisions are made by authorised people.
Root cause analysis
Modules connected into one quality system
We have grouped the modules into three areas of the Quality Management System. 6 modules are already available, and more are joining the platform step by step.
QMS governance & quality loop
Document lifecycle, change control, CAPA, internal audits and feedback from the market
- Quality Management System (QMS) Documents · soon
- Change Control · soon
- CAPA
- Internal Audit · soon
- Feedback · soon
Production, environment & operations
Product realization, work environment, measurement control, infrastructure and purchasing
- Product Realization · soon
- Work Environment & Contamination Control · soon
- Monitoring & Measuring Equipment Control · soon
- Infrastructure
- Purchasing
R&D, product management & people
Product management, design and development, training, HR and the AI assistant
- Product Management
- Design & Development · soon
- Training
- HR · soon
- NexiMed AI
Want to get to know each module in detail?
On the offer page you will find descriptions of the available modules: their features, links to other modules, frequently asked questions and the requirements they help you meet.
What changes in the quality team's work
Records, deadlines and decisions in one place – instead of spreadsheets, binders and mailboxes.
Deadlines and statuses in view
The date of a device's next inspection, a supplier's next evaluation and audit, an overdue CAPA marked in red. You see what needs attention without going through spreadsheets.
Modules that know about each other
A training can be evidence of CAPA actions, a device is linked to the products it is used to manufacture, and from a material you go to its supplier.
AI prepares, a person decides
NexiMed AI generates training tests from procedures, reads the CoA on batch receipt and proposes possible root causes in CAPA. The test is added, the batch released and the cause chosen by an authorised person.
Secure infrastructure for your quality data
NexiMed runs in the AWS cloud and data is encrypted with AES-256. Every change in the system is recorded in its history.
Hosted on AWS
The platform runs on Amazon Web Services infrastructure.
AES-256 encryption
Data stored in NexiMed is encrypted with AES-256.
Change history
Every record keeps its history – you can see who changed what and when.
NexiMed implementation in 4 steps
A clear path – from analysing your processes to training your team.
Process analysis
We review your procedures and forms to fit the system to how your company works.
Roles and workflows
We set up user permissions, approval paths and module parameters.
Data migration
We move your existing data – e.g. supplier list, equipment register and training records – into NexiMed.
Team training
We train your users to work in NexiMed using examples from their everyday processes.
See how NexiMed can organise the quality processes in your company
Book a presentation – we will show the available modules in action and discuss how to configure them to your company's procedures.
Have questions?
Let's talk about your processes.
Not sure which package to choose? Or maybe you need a custom integration? Our engineers will be happy to help.