An H-ISAC Navigator Webinar
With increasing regulatory scrutiny, manufacturers must navigate varying cybersecurity requirements across markets. This webinar will provide key insights into aligning your security practices with both the EU's MDR/IVDR and the FDA's guidelines to ensure compliance and protect patient safety.
Key Topics & Learnings:
- EU vs. US Cybersecurity Guidelines: Compare the regulatory frameworks of the EU and US, highlighting key differences and overlaps.
- Lifecycle Documentation Requirements: Understand documentation needs at each stage, from pre-market to post-market, across both regions.
- Harmonizing Cybersecurity Efforts Globally: Learn best practices for aligning your cybersecurity strategy across international markets.
- Real-World Rejection Examples: Review common cybersecurity pitfalls leading to market approval rejections, with actual feedback from regulators.
- Practical Compliance Tips: Get actionable guidance on preparing for cybersecurity audits and avoiding regulatory delays.
Our team of FDA analysts and cybersecurity experts provide robust and actionable cybersecurity roadmaps to ensure you meet FDA requirements. Get the Medcrypt advantage today!
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