Sitemap - 2023 - Let's Talk Risk!
LTR Weekly Digest #17 - 23rd December, 2023
LTR 33: AI and the future of work for QA/RA professionals
ISO 14971 Fundamentals: Characteristics related to safety
Quick Tip: When developing new medical devices, optimize both benefits and risks
LTR Weekly Digest #16 - 16th December, 2023
LTR 32: A new paradigm for building connected medical devices
Case Study: When silent changes in one device cause incompatibility with another
Quick Tip: Watch out for the severity bias when analyzing medical device risk
LTR Weekly Digest #15 - 9th December, 2023
LTR 31: Focus on the purpose to measure process effectiveness
Webinar 4: Why FMEA alone is not sufficient for risk analysis
Quick Tip: Safety is important but not the only objective for risk management
LTR Weekly Digest #14 - 2nd December 2023
LTR 30: It is time to unfake risk management!
Medical Device News Update - October 2023
Quick Tip: A hazard is more than just a potential source of harm
LTR Weekly Digest #13 - 18th November, 2023
LTR 29: Challenges and opportunities for digital technologies in medical applications
Challenges and opportunities for digital technologies in medical applications
ISO 14971 Fundamentals: Reasonably Foreseeable Misuse
Quick Tip: Focus on quality system processes that most directly impact safety and effectiveness
LTR Weekly Digest #12 - 11th November, 2023
LTR 28: It is time to build equity in medical device design control
It is time to build equity in medical device design control
Case Study: When benefit-risk falls below expectations despite solid clinical data
Quick Tip: Use a patient-focused method when estimating risk
LTR Weekly Digest #11 - 4th November, 2023
Celebrating 25 Let's Talk Risk! Conversations
Webinar 3: A practical approach for analyzing benefit-risk of medical devices
Quick Tip: Build a strong link between clinical evaluation and risk management
LTR Weekly Digest #10 - 28th October, 2023
LTR 27: Practicable or not, that's the question for risk control
Practicable or not, that's the question for risk control
Medical Device News Update - September 2023
Quick Tip: Follow FDA action to learn about safety and effectiveness of AI/ML devices
LTR Weekly Digest #9 - 21st October, 2023
LTR 26: Seek clinical input early in development to achieve market success later
Seek clinical input early in development to achieve market success later
ISO 14971 fundamentals - policy for establishing criteria for risk acceptability
Quick Tip: Simplifying IVD risk management
LTR Weekly Digest #8 - 14th October, 2023
LTR 25: Career tip - learn to effectively communicate regulatory risk in business terms
Career tip - learn to effectively communicate regulatory risk in business terms
Case study - when miscalculating risk leads to a warning letter
Quick Tip: Simplifying IVD risk management
LTR Weekly Digest #7 - 7th October, 2023
LTR 24: Clinical evaluation is a lifecycle process, not a one-time activity
Clinical evaluation is a lifecycle process, not a one-time activity
Webinar 2: two ways to estimate the probability of harm
Quick Tip: FDA's 510k database is a treasure trove of information for medical devices
LTR Weekly Digest #6 - 30th September, 2023
LTR 23: Focus on intended use in the clinical environment for risk management of IVDs
Focus on intended use in the clinical environment for risk management of IVDs
ISO 14971 fundamentals: understanding sequence of events
Quick Tip: Simplify CSV with a risk-based approach
LTR Weekly Digest #5 - 23rd September, 2023
Ep 22: Think of post-market surveillance as a value adding business process
Think of post-market surveillance as a value adding business process
Medical Device News Update - August 2023
2023 world patient safety day challenge
Quick Tip: Feeling stuck? Focus on patient safety, not compliance when managing risk
LTR Weekly Digest #4 - 16th September, 2023
Ep 21: Why risk practitioners must build the empathy muscle
Why risk practitioners must build the empathy muscle
Webinar 1: 7 essential elements of a risk management plan
Quick Tip: Get comfortable with probability when thinking about risk
LTR Weekly Digest #3 - 9th September, 2023
Insights from 5 recent Let's Talk Risk! conversations: July-Aug 2023
Case study: Using post-market data to evaluate changes in risk level
Quick Tip: Focus on the customer not compliance in your procedures
LTR Weekly Digest #2 - 2nd September, 2023
Ep 20: Team diversity helps boost competence in risk management
Team diversity helps boost competence in risk management
A quick summary of 5 recent FDA guidance documents - Aug 2023
Quick Tip: Start with system safety requirements for your medical device
LTR Weekly Digest #1 - 26th August, 2023
Ep 19: How QA/RA professionals can help drive innovation in AI/ML
How QA/RA professionals can help drive innovation in AI/ML
Medical Device News Update - July 2023
Quick Tip: 3 benefits of risk-based thinking
Ep 18: Risk based approach to building a QMS in a startup
Risk based approach to building a QMS in a startup
ISO 14971 fundamentals: risk management file
Quick Tip: 3 questions to ask about your post-market surveillance process
Ep 17: Risk management lessons learned from running the Boston marathon
Risk management lessons learned from running the Boston marathon
Webinar 1: 7 essential elements of a risk management plan
Case Study - Lessons from an FDA warning letter
Quick Tip: engaging with the FDA on risk management
Ep 16: Clinical evaluation is now more important than ever under EU-MDR
Clinical evaluation is now more important than ever under EU-MDR
Free webinar: Top management responsibility for risk management
Medical Device News Update - June 2023
LTR is launching premium features for paid subscribers
Quick Tip: 4 questions to ask when confronting a recall
Quick Tip: 5 reasons you may invite unwanted FDA scrutiny
Introducing Chat for the Let's Talk Risk! Community
Quick Tip - A culture of quality naturally leads to excellence in risk management
Insights from 5 recent Let's Talk Risk! conversations: May-June 2023
Quick Tip: Clearly define electronic interfaces of interoperable devices
Ep 15: Collaboration is the secret sauce for success in risk management
Collaboration is the secret sauce for success in risk management
Quick Tip - Be aware of the effect of risk perception
Ep 14: The most important question for risk management: who is taking the risk?
The most important question for risk management: who is taking the risk?
Medical Device News Update - May, 2023
Quick Tip - Make safety risk management a business priority
Ep 13: Compliance: an obstacle or an opportunity?
Compliance: an obstacle or an opportunity?
Invite your friends to read Let's Talk Risk!
Small probabilities can distort our judgment about the significance of change
Quick Tip - Proactively manage cybersecurity threats and vulnerabilities
Ep 12: Risk lessons learned from working on a hydrogen-powered car
Risk lessons learned from working on a hydrogen-powered car
When relying on user action to mitigate risk, be extra vigilant
Quick Tip - Create a process to update risk files
Ep 11: Understanding a physician's view on risk
Understanding a physician's view on risk
A quick poll - evaluating benefit-risk of medical devices
Beware the severity bias when analyzing risks
Insights from 5 recent Let's Talk Risk! conversations: Apr-May 2023
Medical Device News Update - April, 2023
Ep 10: Safety is important, but not the only objective for risk management
Safety is important, but not the only objective for risk management
Book review - Hazard Analysis Primer
Ep 09: Tips for a risk-based approach to auditing Quality Systems
Tips for a risk-based approach to auditing Quality Systems
One reason you might be systematically underestimating risk
Ep 08: Understanding the interface between clinical evaluation and risk management
Understanding the interface between clinical evaluation and risk management
How artificial intelligence is advancing medical device innovation
Ep 07: Risk management of IVDs requires a different approach
Risk management of IVDs requires a different approach
A 5 minute summary of 5 recent FDA guidance documents - May 2023
Insights from 5 recent Let's Talk Risk! conversations
Medical Device News Update - March, 2023
Best practices for using FMEAs for medical devices
Best practices for using FMEAs for medical devices
Tools and tips: How to use FDAs 510(k) database
Keep Quality simple by applying critical thinking
We want to do it "right", but we are stuck!
Getting comfortable with a probabilistic way of thinking about risk
When compliance leaves the customer stranded
It's time to start applying system safety to medical devices
Medical Device News Update - February, 2023
Understanding risk-based thinking
The real reason why post-market safety surveillance must become a top priority
Understanding FDA's perspective on risk
Risk management lessons from a medical device recall
5 signs your medical device could become a target of FDA scrutiny
A business case for Quality Culture
FDA guidance offers a regulatory path forward for interoperable devices
Why we need a stronger focus on medical device safety
Cybersecurity is the next frontier in medical device risk management
Why failing to update your risk matrix is a problem