Market-specific requirements for medical device wireless module compliance

In our first wireless compliance webinar, we highlighted the two main pathways to medical device wireless compliance: modular approval and system approval. In our second wireless compliance webinar, we provided an in-depth look at modular approval requirements in the US and Europe so you can determine the best compliance strategy for your product. 

In our third wireless compliance webinar, we will take an in-depth look at global market access requirements for 15+ countries in Europe, Asia, Latin America, and beyond. For each country, we will highlight the following: 

• Regulator 
• Allocated Frequencies for 13.56 MHz, WLAN 2.4 GHz, WLAN 5 GHz 
• Modular or System level approval accepted 
• Delivery Path: Test Reports accepted (FCC or EU) or In-country Testing 
• Number of samples required for submittal 
• Local Representative or Importer required for submittal 
• Certificate validity 
• Average turnaround time to obtain approval 

 

Jul 11, 2019

Maja Bland received her Bachelor of Arts degree in International Relations Global Studies and Spanish Language from the University of Minnesota. In addition, Maja has a Master of Science in Project Management from Saint Mary’s of Minnesota. She recently joined UL’s Global Market Access (GMA) team; however, she has worked in global regulatory trade compliance for 13 years. Maja resides in Minnesota, USA. 

Ms. Bland has been dedicated to the field of GMA and she is heavily involved in helping manufacturers with global compliance strategies. Maja and the UL GMA teams work together to leverage UL’s global footprint to ensure a smooth product launch within their target countries. For UL, GMA means integrated solutions for safety & EMC testing, wireless approvals and energy efficiency services. Maja is able to help customers by guiding them through the GMA process every step of the way.

Holly Gillespie is a Global Market Access Operations Leader located in Fremont, California. Holly has been involved in assisting customers develop global compliance strategies for over 20 years. She has twenty five years of experience in the testing, inspection, and certification industry. She values helping customers succeed in the marketplace by partnering with them to develop a compliance strategy to get products to market quickly and efficiently.

PRESENTERS

  • Maja BlandMaja Bland
    Senior Project Coordinator | UL

     

     

    Holly GillespieHolly Gillespie
    Operations Leader | UL