Certifications & Compliance
We are proud to be certified by leading national and international bodies, reflecting our commitment to quality, safety, and excellence.
Our Certifications
At Sovell, quality isn't just a standard — it's our promise. Our certifications validate our dedication to manufacturing excellence, safety, and continuous improvement across all our operations.
ISO 13485:2016
Quality Management System for Medical Devices
ISO 9001:2015
Quality Management System
Certificate of Compliance
Medical Devices Directive 93/42/EEC
FDA Compliance
Food and Drug Administration Standards
GHP Certified
Good Hygiene Practices
GMP Certified
Good Manufacturing Practice
All certificates are valid and regularly audited by governing bodies
Registered & Compliant
Sovell Health is fully registered with all required government authorities, ensuring transparency and trust in every business transaction.
IEC Registration
BALPK8346M
GST Registration
02BALPK8346M1ZB
All registrations are verified and compliant with government regulations