We take compliance very seriously
Dr.BrightWell Pvt Ltd. has a manufacturing facility with high-grade international Level Standards.
ISO 9001:2015 : 250425Q109
Our ISO 9001:2015 certification reflects our commitment to delivering consistent quality across every aspect of our operations. It signifies that our internal systems meet international standards for quality management, ensuring customer satisfaction, continuous improvement, and operational excellence. At Dr.Brightwell we don’t just build healthcare products — we build trust through uncompromised quality.
WHO-GMP COMPLIANCE : 250425W108
Being WHO-GMP compliant means that Dr.Brightwell follows the highest international standards for Good Manufacturing Practices as laid out by the World Health Organization. This certification ensures our products are manufactured in hygienic, controlled environments with strict quality control at every stage — guaranteeing safety, consistency, and reliability in every unit we deliver.
ISO 13485:2016 : 250425M107
Dr.Brightwell is proud to be ISO 13485 certified — the global standard for quality management systems specific to medical devices. This certification validates our commitment to designing, producing, and delivering safe and effective healthcare products with rigorous quality control, regulatory compliance, and traceability at every step.
uSFDA COMPLIANCE : 250425103
Dr.Brightwell is USFDA registered, ensuring that our healthcare products meet the stringent safety, efficacy, and quality standards set by the U.S. Food and Drug Administration. This recognition reflects our compliance with international best practices and allows us to serve customers across global markets with confidence.
CE COMPLIANCE : AMC:CE-1308
Our CE certification ensures that Dr.Brightwell products meet the essential requirements of European health, safety, and environmental protection regulations. It’s a mark of trust, assuring customers that every product we offer is tested, reliable, and approved for international markets.
IMPORT EXPORT CODE : AAMCB9695D
With a valid IEC issued by the Directorate General of Foreign Trade (DGFT), Dr.Brightwell is fully authorized to import and export medical devices and healthcare products. This unlocks our ability to expand internationally, strengthen our global presence, and bring trusted healthcare solutions beyond borders.