From daily quality work
to audit-ready
Automate ISO 13485, MDR, and FDA compliance. All-in-one platform for medical device manufacturers that turns bureaucracy into competitive advantage.
PCBC S.A.
App built in collaboration with specialists from the Polish Centre for Testing and Certification.
Everything in one place
Integrated modules for complete quality control.
eDMS
Electronic document circulation.
eQMS
Quality and process management.
Risk Analysis
ISO 14971, FMEA, Risk Matrix.
Training
Team competency management.
Traceability
Complete requirements traceability matrix.
Infrastructure
Security and scalability.
Connect your tools
into one ecosystem
Ready-made plugins for popular ERP systems and engineering tools.
Documents
Import from Word/Google Docs
Processes
Sync with Jira/Asana
API First
Full access via REST API.
Security
Encrypted TLS 1.3 connections.
Logs
Complete integration event history.
Your Intelligent
Compliance Partner
Leverage the power of artificial intelligence to accelerate documentation, risk analysis, and audit preparation. NexiMed AI understands the context of your medical devices.
Automatic Drafts
AI generates initial versions of procedures, instructions, and reports compliant with ISO 13485.
Editing Assistant
Checks terminology consistency, formatting, and numbering across all documentation.
Regulatory Change Analysis
Monitors changes in MDR, FDA, and standards – suggests what to update.
How does it work? Simple and effective
Implementation in 3 simple steps.
Configuration
We set up system parameters according to your procedures.
Migration
We import your existing documents and data.
Start
Your team starts working in the new system.
Good morning
Masz 3 documents do podpisu.
Quality in your pocket
Access to tasks and signatures from anywhere.
Mobile signature
Approve documents on your phone.
Notifications
Stay up to date with tasks.
Scanner
Scan device QR codes.
Your data is
secure
Banking standards in medical data protection.
Infrastructure
EU servers, data redundancy.
AES-256
Bank-grade encryption at rest & transit.
Backup
Point-in-time recovery & Immutable Logs.
Trusted by
MedTech industry leaders use NexiMed.
"The system significantly accelerated our audits."
"Essential tool for every device manufacturer."
"Intuitive interface and great support."
FAQ
Answers to frequently asked questions.
Join the
waitlist
Be one of the first users.
To proste. Kliknij przycisk "+ Nowe" na dashboardzie lub powiedz mi szczegóły błędu tutaj, a utworzę szkic za Ciebie.
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.