FDA 21 CFR Part 11
ISO 13485
MDR/IVDR
HIPAA
Why Health Leaders Choose Heliosphere.
Audit-Ready Compliance
Automated documentation and traceability reduces regulatory risk
Unified ERP & e-QMS
Break down data silos. Connect quality processes directly with operational data
Accelerated Market Access
Faster approvals and streamlined product lifecycles get treatments to patients sooner
Introducing Heliosphere e-QMS.
- Document Control
- CAPA Management
- Training Records
- Supplier Quality
- Risk Management
Our valued partners
We are in good company.
Amsterdam
Fruitful collaboration since 2014
Firenze
Flourishing together since 2016
Nairobi
Successful collaboration since 2019
Madrid
Thriving partnership since 2021
What we offer to our customers
Tailored Solutions
We provide personalized solutions to meet your unique needs. Our team works with you to ensure optimal results from start to finish.
Eco-Friendly Solutions
Customer satisfaction is our priority. Our support team is always ready to assist, ensuring you have a smooth and successful experience.
Quality and Excellence
With extensive experience and deep industry knowledge, we provide insights and solutions that keep you ahead of the curve.
Expertise and Knowledge
We offer cutting-edge products and services to tackle modern challenges. Leveraging the latest technology, we help you achieve your goals.
