Partners & Certifications

Drive business forward by partnering with us

We’re proud to partner with top-notch companies to deliver services we can be proud of.

We proudly collaborate with hospitals, distributors, healthcare systems, and OEM clients who value quality, innovation, and compliance. Together, we create a future where surgical care is safer, smarter, and more accessible.

Why our credentials are important

In a tightly regulated industry like Medtech, compliance is everything. Our certifications are more than documents — they’re a reflection of how we build, test, validate, and ship every product. They give our partners the confidence to deliver Futura solutions in operating rooms across 80+ countries.

Our company has been certified with all relevant regulatory and quality certifications.

CE 2460 (EU MDR)

Futura Surgicare is CE certified for Class IIB and Class III medical devices, and also holds a CE Design Certificate, ensuring our products meet the highest standards of safety, quality, and compliance under EU regulations.

ISO 13485:2016

Global benchmark for medical device quality management systems.

ISO 9001:2015

Excellence in overall quality and process control.

WHO-GMP

Recognized standard for pharmaceutical-grade manufacturing hygiene and safety.

UKCA (UK Conformity Assessed)

For post-Brexit compliance in the United Kingdom.

CFDA (China Food & Drug Administration)

Certification to market medical devices in China.

SFDA (Saudi Food & Drug Authority)

Ensures Futura meets healthcare regulations in the Middle East.

In Progress: US FDA, MDSAP

Our global compliance roadmap includes high-bar approvals to strengthen worldwide trust.

WE ARE CERTIFIED

How we work with our partners

We build long-term, trust-based partnerships by offering regulatory-ready documentation, OEM/private label flexibility, and dedicated support from our export, R&D, and logistics teams. Whether you’re a hospital, distributor, or global brand, we adapt to your needs with quality-assured, scalable solutions.

Reviewed on
5/5
1994

We are Founded

85+
Countries
Global distribution reach
850+
Distributors

Across Globe

Contact us

Partner with Us for Advanced Surgical Solutions

We’re here to support you — whether you’re a hospital, distributor, OEM partner, or healthcare professional. Let’s explore how Futura Surgicare’s products and expertis can enhance your surgical outcomes.

Your benefits:
What happens next?
1

We Schedule a call at your convenience 

2

We do a discovery and product briefing

3

Receive a customized product or partnership proposal

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