Diagnostic Medical Device Services
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Manufactured by Gerresheimer AGbased in GERMANY
An overview of the whole world. Complex tasks are mastered at Gerresheimer Medical Systems through our international 40-member Project Management team. To this purpose we form specialist teams that plan, organize and process projects with the customer promptly and ...
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Manufactured by Gerresheimer AGbased in GERMANY
Concept, product and process development of medical and diagnostic products. Reduced development time, development costs, and project risk by design for ...
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Manufactured by NextPhase Medical Devices LLC.based in 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 ...
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Manufactured by ORGENTEC Diagnostika GmbHbased in GERMANY
Our in vitro diagnostic medical devices (IVD) are CE marked. Our quality management system is certified according to ISO 13485 in the latest ...
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Manufactured by Visia Lab Srlbased in ITALY
constant growth over the years thanks to the development of proprietary technologies and a constant commitment to research and development of innovative, disruptive in-vitro diagnostic medical devices. All phases of the design and production process are carried out at the San Giovanni Valdarno production ...
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by STEMartbased in USA
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro ...
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by BiotechExecbased in USA
Benefit from the unparalleled diversity of our Senior Executive Advisory Team (The ?SEAT’), a collective of biotech, pharma, medical device, diagnostics, and digital health specialists, who utilise their wide range of skills within the field and their shared commitment to the development of the life sciences sector, to directly benefit ...
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based in USA
: Professional digital health services to create and/or implement your digital health solution on the BrightInsight Platform, including apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD), Data integration and management of a broad range of ...
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Manufactured by Ginolis Ltdbased in FINLAND
Ginolis provides design support to ensure that medical device and diagnostic designs are automation ready. The ability to identify and correct downstream issues will lead to reduced cycle time, higher product quality, and lower development and manufacturing costs. ...
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Manufactured by Quay Pharmabased in UNITED KINGDOM
Quay Pharma has successfully updated its license with the MHRA to include commercial ...
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based in USA
BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...
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based in USA
Strategic regulatory planning and implementation is a critical component of any product development program. Understanding the regulatory pathway up front not only allows for clarity in the development process but can also save valuable time and ...
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Manufactured by InBios International, Incbased in USA
We know that our success depends on your success. We work efficiently to meet the needs of our customers while abiding by our commitment to quality. ...
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Manufactured by Chemical Inspection & Regulation Service Limited (CIRS)based in CHINA
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. Quality Assurance & Compliance. Risk Assessment & Management. ...
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Manufactured by ViVO Smart Medical Devices Ltd.based in UNITED KINGDOM
Trusted Quality Manufacturing services for Medical Devices and healthcare technologies. We provide manufacturing expertise to Medtech companies and Healthcare professionals who require a trusted supplier of high quality outsourced contact manufacturing ...
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Manufactured by in.vent Diagnostica GmbHbased in GERMANY
ICS is the newest expansion of our service portfolio. We have harnessed our 20 years of expertise in diagnostic studies to conceive a new level of IVD-services: A complete all-round package covering every step of diagnostic assay validation, including all performance studies, study protocols, and ...
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based in GREECE
CE Marking is the symbol as shown on the top of this page. The letters 'CE' are the abbreviation of the French phrase 'Conformité Européene' which literally means 'European Conformity'. The term initially used was 'EC Mark' and it was officially replaced by 'CE Marking' in the Directive 93/68/EEC in 1993. 'CE Marking' is now used in all EU official ...
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Manufactured by KSL Biomedicalbased in USA
their need for special resources to achieve and maintain compliance. Team members have worked with all levels of compliance: state, national and international inspectors, regulatory authorities and quality registrars in the laboratory service, medical device, in vitro diagnostic (IVD) device, pharmaceutical, food and supplement ...
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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 GERMANY
In all areas of modern life, people rely on products that are free from pathogenic germs. For medical devices and in medical diagnostics, sterility is ...
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