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Europe Union | Medical Devices |IVD Devices | IVD| CE Mark Registration | Active Implan... - 0 views

www.arazygroup.com/europeanunion

Europe union medical devices IVD mark registration active implant design dossier preparation ISO 13485 eu authorized representative service ce marking markings FDA 510k

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Medical devices are divided into class I, IIa, IIb and III. IVDs are divided into four categories: General IVDs, self-diagnostics, list A and list B. All medical devices exempt class I and General IVDs require the involvement of a Notified Body and the implementation of a quality management system, usually in line with ISO 13485.
arazy-group

Medical Device Registration | Global Medical Device Registration | Medical Devices Stan... - 0 views

www.arazygroup.com/registrationinmorethan53countr

medical device registration global devices standards regulatory consulting CE marking FDA agent ISO 13485 consultant clinical project manager

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    As an international company, we make sure we are available to our clients around the clock through various channels of communication in multiple languages.
arazy-group

Essential Requirements | Medical Device | FDA |Regulatory Designated Agent | FDA Device... - 0 views

www.arazygroup.com/esRegulatoryDossierPreparation

essential requirements medical device FDA regulatory designated agent listing USA agents registration US compliance ISO 13485 and

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Arazy Group - Preparation of a regulatory dossier for the authorities can be cumbersome as It may contain tens of different documents, templates, reports, charts and graphics.
  • arazy-group on 22 Sep 11
     
    Arazy Group helps you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you.
arazy-group

Universal Authorized Representative | FDA Regulatory | Compliance FDA 510 | FDA US Agen... - 0 views

www.arazygroup.com/Univauthorep

universal authorized representative FDA regulatory compliance 510 US agents device listing european medical ISO 13485 design

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    European Union (EU) Authorized Representative, USA Designated agent, China after Sales service, Central & South American registrations holding companies, Japan MAH - Marketing Authorized Holder, Product Sponsor and similar entities are the legal and regulatory bodies a medical device manufacturer needs to source, appoint, contract, pay for and renew annually in order to fully satisfy the product sales clearance requirements.
arazy-group

FDA 510 | FDA US Agents | FDA Device Listing | FDA US Agents | FDA Registration US | FD... - 0 views

www.arazygroup.com/FDA510KFilePreparation

FDA 510 US agents device listing registration regulatory compliance ISO 13485 and requirements

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group help you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you. You can gain from our numerous medical device regulatory and CE marking consulting services.
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