NEWS ROOM

See the latest news from our company below or use the search feature. For more information, contact our head office or the Marketing Communications Manager directly at marcom@arazygroup.com.


 

ARAZY GROUP OFFERS QMS UPGRADE TO ISO 13485:2016 STANDARD

by Arazy Group | Apr 05, 2017
In line with its commitment to making safe and effective IVD and medical devices available worldwide, regulatory affairs firm Arazy Group Consultants Inc. is assisting MedTech manufacturers in meeting the deadline to upgrade their quality management systems (QMS) to the ISO 13485:2016 standard.
 
MedTech firms have until February 28, 2019 to transition their quality management systems from the ISO 13485:2003 and the EN ISO 13485:2012 standards. However, it is recommended that firms start planning their transition as a matter of urgency and that it is completed by early 2018.
 
Arazy Group is ensuring its clients’ procedures meet the latest ISO requirements, enabling them to obtain premarket approval for their products in 100+ countries across the globe both quickly and cost-effectively. Furthermore, as part of its service, it offers quality assurance professionals a two-hour training session on the implementation of the changes.
 
Contact Arazy Group today to discuss upgrading your QMS and to discover how MedTech firms are working smarter with regulatory intelligence and registration management system LICENSALE.COM®.

 

 

Back to Press Room

latest news
  • Apr 9 2018
    MDSAP Transition in Canada

    Health Canada is allowing a "grandfather" period in 2019 for applicants who do not have an MDSAP certificate issued by December 31, 2018....

    Read More
  • Apr 9 2018
    REGULATORY UPDATE - ALPHA BIO

    Italy: Alpha Bios' GSTK (Implant Mount CS) was approved for sale with LICENSALE.COM®....

    Read More
  • Mar 26 2018
    REGULATORY UPDATE - DR. KORMAN LABORATORIES

    Peru: Dr. Korman Laboratories' Dermal Fillers were approved for sale with LICENSALE.COM®....

    Read More
  • Mar 22 2018
    REGULATORY UPDATE - CLARIUS MOBILE HEALTH

    Ecuador: Clarius Mobile Health's Clarius Ultrasound Scanner was approved for sale with LICENSALE.COM®....

    Read More
  • Mar 22 2018
    REGULATORY UPDATE - SPD

    Peru: SPD's CB 9 and CB11 were approved for sale with LICENSALE.COM®....

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP