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Medical Device News Update - April 2024
FDA approvals, warning letters and Class I recalls issued during April 2024
 • 
Naveen Agarwal, Ph.D.
AMA #3: Does ISO 14971 require benefit-risk analysis of ALL individual residual risks?
A common practice in the medical industry is to document benefit-risk analysis of all individual residual risk as an added column in risk assessments…
 • 
Naveen Agarwal, Ph.D.
3
56:50
Webinar 7: How to create a master harms list using standard codes
A step by step method to help you create a master harms list using FDA, IMDRF or MedDRA codes.
 • 
Naveen Agarwal, Ph.D.
1
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ISO 14971 Fundamentals: Characteristics related to safety
 • Naveen Agarwal, Ph.D.
5
Webinar 7: How to create a master harms list using standard codes
 • Naveen Agarwal, Ph.D.
1
ISO 14971 Fundamentals - Using standardized terms for more accurate risk analysis
 • Naveen Agarwal, Ph.D.
2
Medical Device News Update - December 2023
 • Naveen Agarwal, Ph.D.
Webinar 4: Why FMEA alone is not sufficient for risk analysis
 • Naveen Agarwal, Ph.D.
LTR 33: AI and the future of work for QA/RA professionals
 • Naveen Agarwal, Ph.D.

LTR weekly digests

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3:36
LTR Weekly Digest #37 - 18th May, 2024
Catch up on this week's articles - bonus free article, medical device news update, LTR conversation about startup success, and a quick tip for linking…
 • 
Naveen Agarwal, Ph.D.
4:08
LTR Weekly Digest #36 - 11th May, 2024
Catch up on this week's articles - Analyzing risk of delay in treatment, a roundup of 10 risk-related LinkedIn posts, and a quick tip about creating a…
 • 
Naveen Agarwal, Ph.D.
3:58
LTR Weekly Digest #35 - 4th May, 2024
Catch up on this week's articles - Webinar recording, a clinician's view on AI/ML enabled medical devices, and a quick tip about QMSR.
 • 
Naveen Agarwal, Ph.D.

Case studies

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AI in MedTech #1: IDx-DR retinal software for early screening of diabetic retinopathy
A case study to illustrate benefit-risk assessment for an innovative AI-based screening device for early detection of diabetic retinopathy.
 • 
Naveen Agarwal, Ph.D.
2
QMSR is coming. Are you ready?
FDA is expected to finalize the proposed Quality Management System Regulation in 2024. The revised regulation adds a heavy emphasis on risk in alignment…
 • 
Naveen Agarwal, Ph.D.
Case Study: When silent changes in one device cause incompatibility with another
An uncontrolled change in syringe dimensions caused compatibility issues with an infusion pump resulting in overdose, underdose, delay in therapy and…
 • 
Naveen Agarwal, Ph.D.
4

Webinars

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Medtech news

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AMA on Risk Management

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Risk management fundamentals

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Quick tips

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Let's Talk Risk!
Let's Talk Risk!
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