Wireless MedTech: Navigating Global RF Compliance

Medical Device Global Market Access

This episode offers medical device manufacturers an essential overview of navigating global wireless compliance when integrating radio frequency (RF) modules. We explore crucial considerations from selecting RF module suppliers and understanding international certification pathways—like modular versus system-level approvals—to compiling necessary documentation and addressing specific restrictions for medical applications. Learn how early planning and a clear understanding of each target market's regulations can streamline your path to launching wireless medical devices worldwide. Key Questions: • What are the first steps when planning international wireless compliance for your medical device? • How can you effectively vet RF module suppliers for global markets? • Modular vs. System-level approval: Which path is right for your wireless device and what are the hidden complexities? • What critical documentation will you need from your RF module supplier for international submissions? • Are there unique regulatory challenges when using wireless modules in medical applications, like data transmission or SAR? • How do you ensure your wireless medical device meets varying country-specific technical standards? • What strategies can help avoid costly delays in getting your wireless medical device to global markets? • Who typically owns the RF module certification, and does it need to be transferred? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of wireless compliance and global market access for medical devices—in over 30 markets worldwide, including complex regions for RF certification. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.