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Biolitec: Contact. Biolitec AG Untere Viaduktgasse 6/9 A-1030 Vienna Tel.: +43 1 3619 909 50 Fax: +43 1 3619 909 99 Email: info[at]biolitec.de Internet: www.biolitec.com biolitec biomedical technology Otto-Schott-Str. 15 07745 JenaGermany Tel.: +49 (0) 3641 519 53 0 Fax: +49 (0) 3641 519 53 33 Email: info[at]biolitec.de Internet: www.biolitec.com Administration & Marketing Brühler Str. 30 53119 BonnGermany Tel.: +49 (0) 228 979 67 0 Fax: +49 (0) 228 979 67 99 Please address any questions regarding our products or therapies to the national representative or local branch.

biolitec: Contact

MR Compatible Equipment Vendors. 20141003-medtech-brochure-digital-1. Guide_dm_gb_050310.pdf. MDDI Medical Device and Diagnostic Industry News Products and Suppliers. Links. Equipments - Quipu. Julight S.r.l. C_17_pubblicazioni_2352_allegato. Le indagini cliniche dei dispositivi medici. Con la pubblicazione Le indagini cliniche dei dispositivi medici si intende fornire una breve e pratica illustrazione della vigente normativa nazionale ed europea - comprese le linee guida europee (MEDDEV) - in materia di indagini cliniche con dispositivi medici e di chiarire il ruolo del Ministero della salute nel processo di autorizzazione di tali indagini.

Le indagini cliniche dei dispositivi medici

La pubblicazione è rivolta a tutti gli operatori che possono essere interessati all’argomento: Fabbricanti, Sponsor, Comitati Etici, Sperimentatori, Clinici, Associazioni di pazienti ed ulteriori soggetti interessati e non pretende di costituire una guida su questioni etiche o decisionali relative alle indagini cliniche dei dispositivi. Durante lo sviluppo del testo, si è tenuto conto dei più frequenti e ricorrenti quesiti e problemi rappresentati alla Direzione generale dei dispositivi medici e del servizio farmaceutico del Ministero della salute (DGDMF), con l’intento di fornire un utile orientamento. OPIS. Locations. A global CRO, Medpace is strategically mapped to support clinical studies around the world. Accovion : Regional coverage. Accovion pursues a dynamic and coherent internationalization growth strategy and has established multiple subsidiaries across Europe over the past years: Czech Republic, France, Italy, Poland, Russia, Romania, Spain and United Kingdom.

Accovion : Regional coverage

This internationalization strategy supported by a strong partnership concept allows Accovion to successfully operate in more than 20 countries. We ensure consistency within our international teams. Our local expertise in offices across Europe, combined with broad experience, enables us to deliver the support that our clients need, where and when needed. Donawa Lifescience Consulting - Medical Device EU/US Quality and Regulatory Services. Locations. Medical Electronics ¦ Medical Device Software for Healthcare Industry. Specialist Areas Medical Electronics development to ISO 13485 and IEC 60601 Medical Imaging systems (ranging from Gamma rays, infra-red and visible light) Medical Device software development including real-time embedded and user interfaces Systems engineering and electronics design Medical device motion control linked with continuous and tomographic imaging, high and low power Active noise and vibration control Data acquisition and processing Healthcare user interfaces on Windows and Unix Nuclear Medicine, PET/CT and MRI Ophthalmology Tele-medicine and endoscopy Medical device connectivity including wireless Healthcare equipment networking (DICOM, HL7, TCP/IP, IPSEC and SSL) For greater detail on our specific skills and services please follow to our Systems & Electronics, Embedded Software, User Interfaces, Turnkey Development or Project Assessment pages.

Medical Electronics ¦ Medical Device Software for Healthcare Industry

Technical Expertise Global Scope Quality & Regulatory Procedures Track Record GENIE Acquisition [1.6MB] Health Language Analytics (HLA) Pty Ltd. BluSense-Diagnostics. The Web's Free ICD-9-CM & ICD-10-CM Medical Coding Reference. Home. Medicinal products for human use - Clinical trials. Medical devices - Interpretative documents. Guidance Documents - About Guidance. What is guidance?

Guidance Documents - About Guidance

Good Guidance Practice (GGP) documents are documents prepared for CDRH staff, regulated industry and the public that relate to: the processing, content, and evaluation of regulatory submissionsthe design, production, manufacturing, and testing of regulated productsthe inspection and enforcement procedures Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both. Most guidance documents exist on the Web and are available via the CDRH Guidance Document page. Dispositivi medici - Conformità CE.