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Medical Device Reporting | Devices | Device Vigilance System | FDA Agent | Medical Devi... - 0 views

www.arazygroup.com/VigilanceReport

reporting devices system FDA agent regulatory registration GMP compliance listing Medical Device Vigilance

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    MDR procedure describing a system for the notification and evaluation of adverse incidents to be known as the Medical Devices Vigilance System.
  • arazy-group on 22 Sep 11
     
    Arazy Group offers a wide range of medical device consultations for fulfilling the different norms and specifications mandatory for medical device clearance and market entry all over the world.
arazy-group

Quality System Audits | Medical Device | IVD Equipment | CE Mark | QMS Activities | FDA... - 0 views

www.arazygroup.com/QualitySystemAudits

quality system audits medical device IVD equipments CE mark QMS activities FDA Taiwan regulation health Canada CMDCAS service professional ISO1348

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.
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Medical Device , ANMAT GMP QMS System Implementation - 0 views

www.arazygroup.com/AnmatGMPQMS

Safety compliance device medical consultants devices

shared by arazy-group on 15 Jul 11 - No Cached
  • arazy-group on 15 Jul 11
     
    Any company that wants to manufacture or import medical devices in Argentina must have a Quality Management System in compliance with ANMAT's GMP. ANMAT GMP QMS System Implementation, Anmat GMP QMS System Implementation.
arazy-group

Global Medical Device Service | GMDN | European Authorized Representative | Medical Dev... - 0 views

www.arazygroup.com/GMDNCoding

global medical device service GMDN European authorized representative devices CE mark consultancy services EU market regulatory affairs consultants designated agent

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Global Medical Device Nomenclature is a system of internationally harmonized generic descriptors used to identify all medical products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
  • arazy-group on 22 Sep 11
     
    GMDN or Global Medical Device Nomenclature is a system of internationally harmonized generic descriptors used to identify all medical products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
arazy-group

Italian NSIS Repertorio Registration | Medical Devices | CE Marked | National Regulatio... - 0 views

www.arazygroup.com/NSISRepertorio

Italian NSIS repertorio registration medical devices CE marked national regulation device FDA consulting listing and diagnostic industry clinical trial data management

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.
  • arazy-group on 22 Sep 11
     
    Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.
arazy-group

Exhibitions | Medical Device Reporting | Devices | Device Vigilance System | FDA Agent ... - 0 views

www.arazygroup.com/Exhibitions

exhibitions reporting devices system FDA agent regulatory registration GMP compliance listing Medical Device Vigilance

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group offers a wide range of medical device consultations for fulfilling the different norms and specifications mandatory for medical device clearance and market entry all over the world.
arazy-group

Canadian Medical Devices Conformity | CMDCAS Canadian Medical Device Conformity - 0 views

arazygroup.com/CanadaCMDCAScompliance

device medical devices consultants Safety compliance in Registration Experts

shared by arazy-group on 25 Jul 11 - No Cached
  • arazy-group on 25 Jul 11
     
    To register of a medical device in the Canadian market a quality management systems must be applied for all medical devices manufacturer except class for I devices. Canadian Medical Devices Conformity, CMDCAS Canadian Medical Device Conformity, Canada.
arazy-group

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.
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SOP | Clean Room procedures | Medical Devices| Manufacture of Medical Devices | Special... - 0 views

www.arazygroup.com/SOP

SOP clean room procedures medical devices manufacture of special manufacturing process packaging assembling quality management system Device

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Arazy Group Bank of SOPs includes procedures for most of the manufacturing processes practiced in the MedTech industry under various environmental conditions.
arazy-group

Canadian Medical Devices Conformity Assessment - 0 views

www.arazygroup.com/CMDCAS

Canadian Medical Devices Conformity CMDCAS Device Assessment

shared by arazy-group on 15 Jul 11 - No Cached
  • arazy-group on 15 Jul 11
     
    To register of a medical device in the Canadian market a quality management systems must be applied for all medical devices manufacturer except class for I devices. Canadian Medical Devices Conformity, CMDCAS Canadian Medical Device Conformity, Canada.
arazy-group

medical device consultants , ISO13485 Quality Management System - 0 views

arazygroup.com/QualityManagementSystem

Medical Device Safety compliance consultants devices

shared by arazy-group on 12 Jul 11 - No Cached
  • arazy-group on 12 Jul 11
     
    Arazy Group provide training, step by step guidance, external auditing and online consulting. Also, we fully outsource quality assurance maintenance services for your organization.
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