Articles

Browse our regulatory articles below or search through our archive.

 


 

HOW MD&M WEST ATTENDEES CAN OVERCOME REGULATORY CHALLENGES

by Arazy Group | Feb 07, 2017
Over the next three days, MedTech professionals will be heading to the 32nd annual MD&M West Conference. While it is important for them to define design techniques and development strategies, as well as leverage the latest breakthroughs in value-based product development, it is just as important to focus on overcoming regulatory challenges.

In order to sell a medical or in vitro diagnostic (IVD) device in a particular country, it must be registered with the local regulatory agency. But without the right expertise and tools, obtaining premarket approval for devices can be a challenge —  regardless of their level of risk, indications of use and technical specifications. And yet, the practice of regulatory affairs remains a fragmented, expensive and inefficient process that is managed manually, mostly through local distributors and consultants.

Regulatory intelligence and registration tool LICENSALE.COM is transforming the way medical and IVD device registration is managed. Being rapidly implemented all over the world, the cloud-based solution can be customized to fit a MedTech firm’s specific needs so it can best meet its business objectives.

With LICENSALE.COM MedTech manufacturers can:

• Reduce regulatory costs by as much as 50% and get approvals for a fixed price
• Expedite time-to-market by 100%
• Quickly gain access to 100+ markets across the globe and even process multiple market clearance applications simultaneously
• Easily control and trace past, present and future registration processes
• Retain ownership of licenses

Through LICENSALE.COM global radiation therapy giant Elekta was able to obtain regulatory approval for 78 products in 16 countries – all in less than a year. If you would like to experience this level of success, contact us today, and we’ll discuss how to transform your regulatory pathway.





 
 
 
 
Category:
  • Blog
Tags:
latest news
  • Jul 17 2017
    REGULATORY UPDATE - XERIDIEM

    UAE: Xeridiems' Entuit Family was approved for sale with LICENSALE.COM®. ...

    Read More
  • Jul 17 2017
    NETHERLANDS TO USE FDA-STYLE UDI SYSTEM FOR MEDICAL DEVICES

    A US-style unique device identification (UDI) coding system for medical devices will be introduced in the Netherlands next year....

    Read More
  • Jul 10 2017
    FDA FINALIZES LIST OF CLASS II DEVICES EXEMPT FROM PREMARKET NOTIFICATION

    The US Food and Drug Administration (FDA) has announced a list of 1,003 class II device types that it believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety...

    Read More
  • Jun 27 2017
    2017 RAPS REGULATORY CONVERGENCE: BOOTH 300/SEPTEMBER 12 LECTURE, 1.15PM

    MedTech regulatory affairs professionals managing the launch of products in new markets and maintaining market approval globally will benefit from the invaluable insights shared during the ‘Regulatory Strategies & Techniques for Faster Market Access’ sess...

    Read More
  • Jun 13 2017
    FDA TO REQUIRE NEW VALIDATION DATA FOR LIST OF REUSABLE MEDICAL DEVICES

    The US Food and Drug Administration (FDA) has unveiled a list of reusable medical devices for which it will require validation data regarding cleaning, disinfection and sterilization as well as validated instructions for use in premarket notification subm...

    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