ISO 13485 Services
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based in USA
Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete ...
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by NSAI Inc.based in 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 ...
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by HingeClinicabased in 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 ...
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Manufactured by Anton Hipp GmbHbased in GERMANY
CERTIFICATION ACCORDING TO DIN ISO 13485. Every year we prove our ability and dedication to high quality. With the certification according to DIN ISO 13485 we meet the highest quality standards. Through a further certification according to Annex 2, we are also able to manufacture disposable products and implants that meet the ...
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Manufactured by LaunchWorks CDMObased in USA
Filling into containers up to 250 liters in an ISO 13485 Quality Management System. ...
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based in GERMANY
To verify and constantly improve the quality and safety of ESYSTA products, Emperra GmbH has a certified quality management system in place that complies with DIN EN ISO ...
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Manufactured by LaunchWorks CDMObased in USA
ISO 13485 automated filling into microtubes, specimen tubes and bottles (up to 60 mLs). Volumes as low as 10 uLs. Filling capacity up to 500,000 units per ...
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based in UNITED KINGDOM
All our devices are manufactured under ISO 13485 Quality Management Standards to ensure that our products are manufactured to the highest quality & standards we feel our customers should ...
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Manufactured by AIV Inc.based in USA
AIV can repair your Telemetry Transmitters to factory equivalent specifications. All repairs are completed in our ISO 13485:2016 certified facility. ...
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based in USA
HIPAA compliant data management. ISO 13485:2016 quality management system. Class II Medical Device: FDA 510(k) ...
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Manufactured by Lumos Diagnosticsbased in USA
Lumos has a world-class ISO 13485 certified OEM manufacturing facility, co-located with its technical R&D team to reduce the time and risk of transfer into production, and for ongoing ...
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Manufactured by Aristotech Industries GmbHbased in GERMANY
Applying the latest forging technology with validated processes. Highest standards ISO 13485 as well as FDA requirements Aristotech forgings guarantee A net–shape premium ...
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Distributed by Bio Sud Medical System srlbased in ITALY
The BIO SUD MEDICAL SYSTEMS Ltd is ISO 13485 and ISO 9001 by DNV GL, ensuring responsible management of the products and services provided in the medical field. The adoption of the Quality Management System constitutes a strategic decision of the organization that needs to show the company's ability to provide its customers, with ...
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Manufactured by Mona Lisa N.V.based in BELGIUM
Due to its longyear experiences Mona Lisa N.V. offers consultation and support in all questions concerning: Quality management (ISO 13485:2016), Technical files for all CE products of class II, III, Technical drawings for special moulds of medical ...
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based in IRELAND
Neuromod maintains a certified Quality Management System to ensure compliance to the applicable regulations in regions that it distributes its devices. Neuromod’s Quality System Certificate ISO 13485: 2016. Neuromod’s CE Certificate Full Quality Assurance. ...
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Manufactured by G.Samaras S.A.based in GREECE
G. SAMARAS S.A. is verified according to EN ISO 9001 and ISO 13485 in the field of Medical Gases installations. The installation operations are executed by specialized personnel ensuring the right installation and compliance to the International ...
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Manufactured by Steris Instrument Management Servicesbased in UNITED KINGDOM
With over 4000 surgical instruments to choose from, our extensive product range offers clinicians absolute peace of mind with a 25 year guarantee. All our instruments are manufactured to the highest standards adhering to ISO ...
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Manufactured by LaunchWorks CDMObased in USA
With full traceability and product purity, our ISO-13485:2016 quality standards ensure all of your products are produced to your exact specifications including commonly overlooked items such as box label placement, component fulfillment into packaging or simply our critical eye for defects in raw ...
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Manufactured by Universal Biosensorsbased in AUSTRALIA
Universal Biosensors has an ISO 13485 accredited facility and quality system in place. This is a state-of-the-art manufacturing facility in Rowville, east of Melbourne that has the ability to manufacture a variety of products through all stages of design and development cycle through to high volume commercial ...
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Manufactured by AIV Inc.based in USA
AIV repairs Lifecare 4100 infusion pumps models in its USA based ISO 13485:2016 certified facility. AIV's trained and experienced maintenance technicians perform specialized repairs to extend the life of your Lifecare 4100 infusion ...
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