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QuickTalk is your go-to podcast offering invaluable insights tailored for early-stage MedTech companies. Our carefully curated content spans various topics and is strategically selected to drive commercial success for your startup. With episodes targeted to just 15 minutes, we provide concise yet comprehensive coverage of critical areas, ensuring easy consumption without compromising depth. Tune in to learn about specific topics and walk away with actionable strategies to propel your startup forward. Whether seeking guidance on regulatory compliance, market entry strategies, or funding avenues, QuickTalk equips you with the knowledge and tools necessary to thrive in the competitive MedTech landscape.
In this premiere episode of QuickTalk, we learn about the changes to the FDA medical device regulations, which are being updated to align better with the ISO 13485 standard. These changes commenced in early 2024, and medical device companies have 24 months to update their QMS and internal processes to align with the new regulations.
Tune in as we explain what this means for you and share some practical tips for achieving compliance.
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