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
ABOUT THE PRESENTERS:
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.
自新欧盟医疗器械法规MDR (Medical Device Regulation 2017/745) 申请日期起，欧盟医疗器械监管当局就发布了一系列新文件及相关支持服务，旨在帮助医疗器械制造商适应新法规变更后的法规环境。 对此，作为在全球范围内经验丰富的医疗器械及IVD器械市场合
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