Sitemap - 2024 - Let's Talk Risk!

LTR 46: Tips to boost effectiveness of medical device post-market surveillance

AMA #3: Does ISO 14971 require benefit-risk analysis of ALL individual residual risks?

Quick Tip: The way to success in FDA inspections is through quality culture

LTR Weekly Digest #31 - 6th April, 2024

LTR 45: A patient's perspective on CGMs

Webinar 7: How to create a master harms list using standard codes

Quick Tip: Adopt, and not fight, AI for career success

LTR Weekly Digest #30 - 30th March, 2024

LTR 44: QA/RA aspects of AI/ML devices, and career tips with Michael Bocchinfuso

Medical Device News Update - February 2024

Quick Tip: Use a risk-based approach to manage SaMD functionality in the cloud

LTR Weekly Digest #29 - 23rd March, 2024

LTR 44: Why we need a new approach to learning medical software and medical AI

ISO 14971 Fundamentals: Risk management plan

Quick Tip: Avoid these red flags during audit of your risk management process

LTR Weekly Digest #28 - 16th March, 2024

RM roundup #2: 10 noteworthy risk-related LinkedIn posts

AMA #2: Is using "no injury" for severity level 1 inconsistent with ISO 14971?

Quick Tip: Simplify your procedures to match your process not compliance.

LTR Weekly Digest #27 - 9th March, 2024

LTR 43: Tips for integrating risk analysis with design controls

Webinar 6: Benefit-risk evaluation of an AI/ML enabled device

Quick Tip: Build equity in the medical device design process to address unintended biases.

LTR Weekly Digest #26 - 2nd March, 2024

RM roundup #1: 10 of my favorite risk-related LinkedIn posts

Medical Device News Update - January 2024

Quick Tip: 3 benefits of early clinical input in medical device design

LTR Weekly Digest #25 - 24th February, 2024

LTR 42: State or event? Thinking clearly about hazards will help you manage risk.

LTR 41: MDSAP, getting ready for QMSR, and career tips with Rick Rios

Quick Tip: Grow your career by understanding and communicating regulatory risk

LTR Weekly Digest #24 - 17th February, 2024

LTR 40: A guest podcast with NAMSA - Part 1

AMA #1: Security risk assessment and vulnerability monitoring

Quick Tip: Integrate clinical evaluation activities in your product development plan.

LTR Weekly Digest #23 - 10th February, 2024

LTR 39: Overcoming challenges in linking risk management with design controls

ISO 14971 Fundamentals - Using standardized terms for more accurate risk analysis

Quick Tip: Gain commitment for risk management with empathy

LTR Weekly Digest #22 - 3rd February, 2024

LTR 38: How medical safety professionals can serve as culture brokers in MedTech

Medical Device News Update - December 2023

Quick Tip: Team diversity is a strength for effective risk management

LTR Weekly Digest #21 - 27th January, 2024

LTR 37: QMSR, Inspection Readiness and Career Tips with Vincent Cafiso

Webinar 5: Getting ready for QMSR

Quick Tip: Leverage AI/ML to drive innovation in MedTech

LTR Weekly Digest #20 - 20th January, 2024

LTR 36: Why we should not overlook the quality-of-life benefit in risk evaluation

AI in MedTech #1: IDx-DR retinal software for early screening of diabetic retinopathy

Quick Tip: Align the level of control with product risk and business needs in a startup

LTR Weekly Digest #19 - 13th January, 2024

LTR 35: Tips for improving collaboration in risk management

QMSR is coming. Are you ready?

Quick Tip: To ensure continued safety, build a robust post-market surveillance process

LTR Weekly Digest #18 - 6th January, 2024

LTR 34: Build a culture of Quality to achieve inspection-readiness at all times

Medical Device News Update - November 2023

Quick Tip: Understand the physician's view on risk early in development