Hospital & Health Care - , ,
Royal Surgicare Pvt. Ltd. is an ISO and CE certified company manufacturing a wide range of disposable surgical products using high-quality raw materials and state of the art manufacturing process, under stringent quality control and sterile environment. Since our work plays a critical role in the demanding field of surgery, our primary objective is to manufacture products that meet strictest hygienic standards with UMAFLOW brand. Our well-planned production unit is situated just 15 Km away from the beautiful city of Ahmedabad, Gujarat with 22500 Sq. Ft Land Area factory building.Infrastructure:The Infrastructure requirements such as Land, Building, and Workshop, Utilities, Equipment's, Communications and Other facilities are sophisticated, dedicated and modernized.• Class 10,000 assembly room.• In house quality control test,• Modernized E. T. O sterilization plant.• Specific work environment is maintained for the production as per Schedule M-III (G.M.P.).• Specific work environment is maintained for the production as per ISO 9001:2015.• Specific work environment is maintained for the production as per ISO 13485:2016.• Specific work environment is maintained for the production as per Medical Device Directive 93 /42/ EEC.Quality Control & Management System:Product realization has planned and developed the process needed through quality management system like,• All manufacturing process under hygienic condition under oneroof.• Incoming raw material testing before it is used in the production process.• In process testing in production quality control and checked at all stages.• Inspection control & checked.• Finish product quality control & testing, it includes physical, chemical, biological and microbiological testing as per statutory requirement and regulatory requirement.
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