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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.
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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.
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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.
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21CFR 820 | FDA QSR | cGMP -FDA GMP Audits to QSR 21 CFR Part 820 for Medical Device C... - 0 views

www.arazygroup.com/FDA-QSR-GMP

21CFR 820 FDA QSR cGMP -FDA GMP Audits to 21 CFR Part for Device Companies packaging medical devices assembling

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have enacted that pharmaceutical and medical device companies must follow GMP procedures and have their own criteria that correspond with their legislations.
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