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26:58
LTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
Watch now | From lab concept to FDA-approval, Viral Thakkar shares how Lungpacer turned breakthrough innovation and risk-based decision making into…
Oct 24
1
16:04
FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
A landmark shift in software validation: FDA’s new CSA guidance promises agility and reduced documentation, but raises tough questions about…
Oct 6
1
1
Medical Device Recalls Part 4: Focus on Ventricular Assist Devices
Part 4 of our deep dive series reveals why two rival heart pumps, built for the same intended use, ended up with such different safety records and…
Aug 13
2
1
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ISO 14971 Fundamentals: Characteristics related to safety
Dec 20, 2023
•
Naveen Agarwal, Ph.D.
11
5
Medical Device News Update - May 2025
Jun 18
•
Naveen Agarwal, Ph.D.
1
Medical Device Recalls - Part 1: High Level Overview
Jul 2
•
Naveen Agarwal, Ph.D.
3
2
Medical Device News Update - March 2025
May 7
•
Naveen Agarwal, Ph.D.
2
LTR 115: Startup Lessons from EU MedTech Shark Tank
Jul 18
6
LTR 102: Collaboration that drives innovation, not delays
Apr 18
5
Case studies
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12:37
Case Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
When success hides risk: The WATCHMAN TruSeal recall shows how scaling too fast can expose hidden procedural hazards. The lesson? Vigilance must evolve…
Oct 20
2
1
16:04
FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
A landmark shift in software validation: FDA’s new CSA guidance promises agility and reduced documentation, but raises tough questions about…
Oct 6
1
1
16:22
Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
The mere existence of guidance, even imperfect guidance, isn’t enough. Manufacturers have to actually implement those security principles diligently.
Sep 22
1
Deep insights
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26:58
LTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
Watch now | From lab concept to FDA-approval, Viral Thakkar shares how Lungpacer turned breakthrough innovation and risk-based decision making into…
Oct 24
1
12:37
Case Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
When success hides risk: The WATCHMAN TruSeal recall shows how scaling too fast can expose hidden procedural hazards. The lesson? Vigilance must evolve…
Oct 20
2
1
28:15
LTR 128: Edward Ball on AI, Vigilance and Future of MedTech Regulation
How AI, standardized vigilance coding, and regulatory clarity are reshaping MedTech risk management, and why asking the right questions and building…
Oct 17
3
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Risk management fundamentals
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AMA on Risk Management
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