Quality & CERTIFICATIONS
At Shaili Endoscopy, we are committed to delivering products that consistently meet the highest standards of quality, safety, and performance. Our comprehensive Quality Management System (QMS) is designed to ensure accountability, traceability, and continuous improvement in every aspect of our operations, from procurement to research and development.
Certified Excellence
EN ISO 13485
Our quality management system is certified under the EN ISO 13485 standard, demonstrating our adherence to international standards for the design, development, production, and service of medical devices.
CE Mark (Per EU-MDR)
Our products meet the rigorous health, safety, and environmental protection requirements of the European Union.
Korean FDA
Our manufacturing facility is approved by the Korean Food and Drug Administration (KFDA), ensuring compliance with stringent regulatory standards for the Korean market.
DCGI Approval
We are approved by the Drug Controller General of India (DCGI), Indian FDA, reflecting our adherence to the highest standards of safety and efficacy for the Indian market.
One Star Export House
Recognized as a One Star Export House, we have demonstrated our capability in exporting high-quality products to global markets, further emphasizing our commitment to international standards of excellence.
Post-market surveillance and continuous improvement
Quality at Shaili Endoscopy is not just about meeting standards; it’s about exceeding expectations. We measure our success by the satisfaction of our customers, achieved through:
Customer satisfaction measurement: Our established post-market surveillance and vigilance systems allow us to gather feedback from customers, enabling us to continually improve our products and services.
Customer feedback integration: We value the input of our clients and partners. Customer feedback is an integral part of our quality management system, driving continuous improvements and innovations in our processes.
Corrective and preventive action (CAPA): We are committed to ongoing improvement. Our team regularly reviews and updates our procedures based on CAPA outcomes, lessons learned, and customer feedback. Continuous improvement is embedded in our culture, with staff meetings and discussions focused on identifying and implementing better practices.
QUALITY • SERVICE • INNOVATION
Our Comprehensive Quality Assurance Program:
is built on a foundation of thorough process control, continuous monitoring, and rigorous testing. We ensure:
Material traceability and accountability from procurement through to corrective and preventive action (CAPA) and R&D. Every material used in our manufacturing process is tracked, tested, and verified for compliance with our stringent standards.
Stringent supplier management: We have established robust criteria for selecting and approving suppliers. All raw materials must meet defined specifications, supported by comprehensive test reports. This ensures that only high-quality materials are used in our production processes.
Process control and validation: We maintain strict control over every step of the manufacturing process. Regular validation of our processes ensures consistency and reliability, so that each product is manufactured using the same proven technology and methods every time.
In-house testing facilities: We conduct thorough biological and chemical testing in our in-house facilities for every product lot, ensuring that each item meets our high standards before it reaches the market.
At Shaili Endoscopy, quality is not just a goal—it’s our promise. We invite you to get in touch with us and experience it for yourself.
Company
Shaili Endoscopy, Plot 210-213, Padra Jambusar Highway, At Post Dabasa, Pin Code: 391-440, Gujarat, INDIA
Products
Gastroenterology
Urology
Bronchoscopy
VGM's Powder Device
Gyanecology
Consumables
Contact
+91 2662 244100
+91 2662 244300
support@shailiendoscopy.com
Make an Inquiry
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UCMDMP Declaration letter
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