ISO 13485 Medical Device Services
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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 ...
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Manufactured by Domico Med-Devicebased in USA
As an FDA-registered and ISO 13485:2016 certified medical device manufacturer, we manufacture products that meet all specifications and relevant regulatory requirements. Thanks to rigorous quality management throughout our manufacturing process, we build medical products that work as intended time and time ...
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Manufactured by Visia Lab Srlbased in ITALY
Our product design and development services provide our customers with a single point of responsibility throughout the entire product making process. Based on the foundation of ISO 13485 for IVD medical devices, our manufacturing team offers flexibility, expertise in laboratory diagnostics and device ...
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Manufactured by KSL Biomedicalbased in USA
), maintain and improve current QMS, meet new regulatory requirements such as those of IVDR, or expand with new needs on QMS. KSL team also provide quality audit services including ISO 13485-, FDA QSIT-, and Medical Device Single Audit Program (MDSAP)-style quality audit, and supplier qualification quality audits. KSL has ...
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Manufactured by Eonex d.o.o.based in CROATIA
In order to identify and address design and engineering flaws in the early stage, we use rapid prototyping technology with 3D printers. The main benefit of this method is quick and cost-effective prototype development, enabling us to identify any deficiencies in the design during the product development phase. In this way, new potential solutions are generated. By selecting the optimal solutions, ...
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Manufactured by SHL Medical AGbased in 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 ...
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Manufactured by Prodromus S.A.based in POLAND
The Prodromus company is a certified service of medical devices in compliance with ISO 13485. We have the necessary equipment and the competence to carry out measurements of electrical medical devices in compliance with ISO 60601 and EN 62353. We invite you to cooperate in the ...
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Manufactured by Visia Lab Srlbased in ITALY
Our product design and development services provide our customers with a single point of responsibility throughout the entire product making process. ...
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Manufactured by Myriad Fiber Imaging Tech Inc.based in USA
The team at Myriad brings extensive expertise in the design, development, and manufacturing of medical devices, including ISO 13485 design controls and the ability to create a full DHF to support the regulatory filing process. Myriad has supported the Research & Development community for years by providing assemblies and ...
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Manufactured by LRE Medicalbased in GERMANY
Always conscientious and quality-conscious: We completely meet our customers’ needs by providing them tailor-made solutions, designed and engineered to always be compliant with regulatory standards. In our fullservice approach that extends from the initial idea to the finished, validated diagnostic device produced in series, we ...
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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 Metecon GmbHbased in GERMANY
An audit is the most effective method to establish certainty that you as the manufacturer or distributor of medical devices are in the position to meet all requirements. Metecon offers comprehensive support in this regard with a wealth of experience and know-how. Take a moment to get an overview of our services. And if you see any need, we ...
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based in FINLAND
We improve quality of life; We develop safe and easy-to-use certified health technology solutions for healthcare professionals and patients to enable more effective ophthalmic diagnostics. We regularly monitor customer satisfaction and collect feedback on our products. We continuously develop both our current products and new product innovations to meet customer needs. Our innovations enhance ...
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based in USA
NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process (PDP) from concept through manufacturing transfer, including support for clinical trials ...
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