vitro diagnostic medical device Services

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BSI VerifEye - Compliance Navigator

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 ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Services Service line

STEMart - Notified Body (EU) Services

Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance requirements for active medical electrical equipment, non-active medical devices, and in vitro diagnostic medical devices. In order to place a medical ...

By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Medical Device Certification Services Service line

Product Development & Design Services

, VISIA LAB has inherited 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 ...

By VISIA LAB Srl based in San Giovanni Valdarno, ITALY.

Testing Services

All devices sold in the European Union must comply with the relevant product directives and have CE ...

By Eurotest Laboratori S.r.l. based in Brugine, ITALY.

CE Certification

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 ...

By SustChem Engineering S.A. based in Athens, GREECE. from Certification Services Service line

ICS – in.vent Clinical Services

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 ...

By in.vent Diagnostica GmbH based in Berlin, GERMANY.

ISO 13485:2003 (Quality Management System – Medical Devices) Services

Certification of quality management system, specifically for medical devices to ISO 13485: 2003 will help the organizations to market their products and also to improve the efficiency of the organization. ISO 13485 Certification is one of the most recognized and respected in the global medical device ...

By Management Systems Solutions based in Ambala City, INDIA.

Audits Services

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 ...

By Metecon GmbH based in Mannheim, GERMANY. from Services IVD - Quality Management Service line

Medical Device Regulation Compliance Services

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 ...

By Chemical Inspection & Regulation Service Limited (CIRS) based in Hangzhou, CHINA.