About us
Quality tools
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
Industry FocusMedical SuppliesMedical EquipmentHealth Care Products
Products/ServicesMedical devices, training, vigilance, CE Marking
Our MarketsWorldwide
No. of EmployeesLess than 5 People
Annual Sales Range(USD)Below US$1 Million
Year Established2005
Legal Representative(CEO)yes
Contact Information
Company NameEurmedes
Contact PersonMr Philippe HAUDEBOURG
Company Address1015 Rue Du Mal Juin, MELUN, France
Postal Code77000
Telephone Number33 0164371958
Mobile Number
Fax Number33 0164371958
WebsiteEurmedes, https://www.bizearch.com/company/Eurmedes_143717.htm
OnlineSince June-11-2006
 
Contact Supplier / Manufacturer

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