Our second deep dive session gives you an overview and a general framework of the new FDA guidance incl. some insights on how to apply it.
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Overview of Latest FDA Guidances and How to Use It |
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Risk‐Informed Credibility Assessment Framework |
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Potential Structure of Technical Documentation |
Simq is the pioneer of in silico medicine and has a team of very experienced engineers, simulation and industry experts. With a global network and strong partners in industry and academia, Simq is one of the leading solution partners in medical technology.
Dr. Sven Herrmann has more than 14 years experience in medical engineering and computational biomechanics. Among others, he is a member of the ASME V&V 40 working group which focuses on the verification and validation of patient-specific computational models.
Director Consulting & Seminars
Simq
Our second deep dive session gives you an overview and a general framework of the new FDA guidance incl. some insights on how to apply it.