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Iso 13485 Services In Asia Middle East
16 services found
by:NSAI Inc. based inNashua, NEW HAMPSHIRE (USA)
ISO 13485 is a necessary certification for medical device manufacturers. It proves that you have a quality manufacturing process and the management standards in place to maintain high quality. ISO 13485 certification is the first step towards achieving compliance with European, Canadian and other regulatory requirements for ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
HingeClinica is a world class partner for Medical Device services. We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and ...
Manufactured by:Achira Labs Pvt. Ltd. based inBengaluru, INDIA
Achira operates out of an ISO 13485 compliant integrated 8000 sq.ft facility for product development and manufacturing. Achira has established supply chain pathways to fully manufacture readers and integrated cartridges on premises. Our facility has completed several regulatory and compliance audits and we have received multiple licenses from CDSCO for various ...
Manufactured by:Avery Dennison Corporation based inPasadena, CALIFORNIA (USA)
Avery Dennison Medical has over 40 years of contract manufacturing experience with certified ISO 13485 quality systems and clean rooms. We offer a wide range of contract manufacturing services including precision coating, rapid prototyping, and limited converting capabilities. Our precision equipment and controlled systems are ideally positioned to manufacture ...
Manufactured by:SHL Medical AG based inZug, SWITZERLAND
SHL implements quality management systems throughout all phases of development and production to ensure consistency in all products. SHL’s quality system complies with FDA Quality System Regulation, Medical Device Regulation, and ISO 13485:2016. The system is regularly audited by customers and monitored internally through stringent ...
Manufactured by:TRIMED (PVT) LTD based inSambrial-Sialkot, PAKISTAN
All instruments of TRIMED are thoroughly scrutinized by our experienced technicians. All instruments are manufactured under the shelter of ISO 9001: 2008 , ISO 13485:2003 & are CE approved. TRIMED sense of production starts from careful selection of raw material, stage to stage of quality control, and above all the instrument handling and ...
Manufactured by:Hitec Medical Co., Ltd. based inShanghai, CHINA
Hitec Medical is a professional manufacturer and distributor of medical disposables mainly in Respiratory, Urology, Anesthesiology and Pain management systems. Hitec follows all relevant China Food and Drug Administration guidelines, and is an ISO 13485 registered company. All Hitec product systems are CE ...
Manufactured by:Penlon Limited based inAbingdon, UNITED KINGDOM
PenlonCare starts with quality in-house design and manufacture, and flexibility of specification. Manufacturing systems at Penlon are certified to ISO 13485:2016 and all our products are CE marked. Penlon systems and facilities are regularly inspected and audited by the FDA, CSA, and other regulatory bodies. We consistently meet and exceed all the required levels ...
Manufactured by:SeaskyMedical based inShenzhen City, CHINA
Medical Device Contract Manufacturing is a procedure in which a medical technology business which has single proprietorship outsources manufacturing to another medical device manufacturing firm. Healthcare contract manufacturing is created in accordance with the OEM’s standards and in accordance with ISO:13485 and FDA criteria. As a prominent medical device ...
Manufactured by:Hong Yang Precision Industry Co., Ltd. based inChanghua, TAIWAN
Hong Yang Precision Industry Co., Ltd. (THY Precision) is a leading medical plastic injection molding manufacturer, certified with ISO 13485 and ISO 9001. We specialize in medical device injection molding contract manufacturing, offering comprehensive services including design & engineering precision injection molds, plastic injection tooling, ...
Manufactured by:Novus Life Sciences based inFotan, HONG KONG
Utilizing advanced biomaterials such as PEEK, PMMA, and Bonlecule, Novus ensures that their products are biocompatible and tailored to meet specific patient needs. Their facilities in Hong Kong operate under stringent ISO 7 cleanroom conditions, and adhere to ISO 9001 and ISO 13485 quality management systems to maintain high ...
Manufactured by:Myra & Co. based inGhaziabad, INDIA
However, what many people identify as "rust" usually turns out to be something else ! All our processes adhere to the stringent criteria laid down under ISO 9001:2008 & 13485:2003 global quality standards and we believe that such high standards coupled with high grade conforming materials ensure that any instrument bearing the FusionKraft™ name will ...
Manufactured by:CardiacSense based inCaesarea, ISRAEL
CardiacSense Is Watching Over You. The CardiacSense watch is a clinically proven medical device that delivers reliable cardiac and blood pressure monitoring, 24/7/365, for as long as needed. Simple to use, the CardiacSense wearable is worn on the wrist just like a regular watch. There are no wires, cables, or connections. It’s completely noninvasive. But behind the watch face lies a ...
Manufactured by:Lumenis Ltd. based inYokneam, ISRAEL
Lumenis provides you with the most comprehensive service and maintenance plans in the industry for medical laser repair and maintenance. Variety of Service Plans were tailored to meet your individual needs and provide you with unsurpassed quality, timely, and cost-effective ...
Manufactured by:NextPhase Medical Devices LLC. based inMansfield, MYANMAR
NextPhase provides comprehensive, integrated contract manufacturing services for finished Class II and III therapeutic and diagnostic medical devices. We have the manufacturing capabilities to ensure quality, speed, and a smooth transition into the ...
by:Clinisys, Inc. based inTucson, ARIZONA (USA)
Vein-to-vein blood transfusion management improving patient safety. Clinisys Blood Bank Management is a comprehensive and fully compliant Blood Bank solution with multi-facility inventory control, automation, and patient safety measures. Our solution enables you to manage blood products issued to patients in a hospital or centralised transfusion ...