Eurmedes
About us | We put at the disposal of the enterprises our know-how in the following domains of activity: Checking your regulatory and quality situation Quality audit and corrective actions Validation and qualification of material Documentary review Quality assurance plan of the products The risk management Development of relative tools to the quality assurance Techniques of synchronized quality system: Mirror quality management CE marking of the medical devices( 93/42/CE dir. ) and diagnosis in vitro( 98/79/CE dir. ) You want to put in service a medical device on the european market We propose you a customized formation The writing of a specification with your suppliers and/or your subcontractors We write your CE marking master file, this whatever are the device class and the assessment mode of the conformity chosen According to your choice, we propose you a complete writing of your file or partial among the following chapters: Answering to the essential requirements of the european directive. Criticity rate of a medical device Risk management(according to the norm ISO 14971) Compilation of the clinical data(reviewing of the literature and/or clinical survey) Biocompatibility(synthesis of the studies: The literature review) Raw materials and manufacturing process Technical performances Labeling(including note of french/english bilingual use) We propose you a complete or partial follow-up of your file for the renewal of the CE marking CE marking by the american market You wish to develop your commercial activity in the united states We counsel you on the procedure applicable to your device(classification, research of predicate device(equivalent device) in the setting of a 510(k), evaluation of the necessary elements. We propose you a customized formation We help you in the writing of your file according to the procedure adapted meadow market notification(510 k), meadow market approval(pma) CE marking by the canadian market You wish to develop your commercial activity in canada We propose you a customized formation We counsel you on the procedure applicable to your device according to its classification We help you in the writing of your file Sectorial vigilance personalized You only have a short time to dedicate to the legislation, to the evolution of the norms and to the actuality of your activity sector We propose you a yearly subscription with quarterly update Authorized vigilance in europe, USA, canada(release of the new texts, text projects, commentaries, quarterly thematic file) Normative vigilance(nf, of it, ISO, astm)(release of the new texts, text projects, commentaries, quarterly thematic file) Competitive and technical vigilance(patents, review of the press, equivalent devices put on the market american, selection of sites internet. ) Scientific vigilance(selection of the international scientific articles appeared in the domain and selection of articles or magazine of medicine course on internet, tools of analysis. ) Vigilance of the materiovigilances(withdrawal of market for europe and USA, together of the declarations of incidents returned in your domain to usa). Authorized appraisals You have a product innovating We advise you on the tests of biocompatibility, the clinical tests and the validation protocols to put in place according the setting of marketing or a subsisdie demand. Quality accompaniment You need an quality accompaniment Optimization of the quality systems according to the referential ISO 9001(2000) and nf en ISO 13485(2004) norms Audit of the quality systems ISO 9001(2000) and nf en ISO 13485(2004) Audit of the quality systems according to the cgmp( American legislation ) Setting up of application of risk management to the medical devices according to the ISO 14971(2001) norm Software validation |
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Industry Focus | Medical Supplies, Medical Equipment, Health Care Products |
Products/Services | Medical devices, training, vigilance, CE Marking |
Our Markets | Worldwide |
No. of Employees | Less than 5 People |
Annual Sales Range(USD) | Below US$1 Million |
Year Established | 2005 |
Legal Representative(CEO) | yes |