Sitemap - 2024 - Let's Talk Risk!
Medical Device News Update - September 2024
Quick Tip: Get your message across with clarity and precision
LTR 70: Best practices for applying usability engineering to medical devices
ISO 14971 Fundamentals: A primer on P1, P2 and how they relate to probability of harm
Quick Tip: Define the intended use early in the design process
LTR 69: A quick update on the 4th edition of IEC 60601
A fast-growing frontier: AR/VR driving innovation in MedTech
Quick Tip: Clock is ticking; start working on your QMSR transition plans
LTR 68: Tips for making customer-focused decisions
QMSR Tip #3: 5 blind spots to check in your CAPA process
Quick Tip: Build deep competence in risk management to help your project team
LTR 67: 3 pillars for defining your IVD risk management strategy
Medical Device News Update - August 2024
Quick Tip: PCCP is a great tool, use it with care
LTR 66: Understanding human factors aspect of augmented reality applications in medical devices
QMSR Tip #2: Ensure product quality and patient safety with risk-based supplier agreements
Quick Tip: To be successful in a startup, don't try to do it all alone
LTR 65: Demystifying risk-based approach vs. risk management
Case study: Neither a SaMD, nor a SiMD; maybe a SaMDA?
Quick Tip: Understand terminology first before going deep into regulations
LTR 64: Opportunities and challenges to leverage PCCP for speed to market
Medical Device News Update - July 2024
Quick Tip: Build credibility through honest communication
LTR 63: A lawyer's perspective on the QMSR transition
Tuning into the Bottom Line: Why QA/RA Professionals Should Listen to Earnings Calls
Quick Tip: Keep the patient in mind when evaluating benefit-risk
LTR 62: Overcoming barriers to cross-functional communication and collaboration
A risk-based approach to CAPA: Insights for QMSR transition with Darrin Carlson
Quick Tip: Take a more holistic view of risk when presenting to top management
LTR 61: Treat human factors as a driver of customer satisfaction, not a check-the-box activity
Communicate to facilitate collaboration, not to impose opinions
Quick Tip: Be aware of differences in risk perceptions
LTR 60: Defining state of the art can be challenging; here are a few tips.
Medical Device News Update - June 2024
Quick Tip: Focus on resilience and agility, not perfection in risk management
LTR 59: FDA's pre-sub program and how it can accelerate medical device innovation
Quick Tip: Treat clinical evaluation as a process, not a report
LTR 58: Tips for clinicians transitioning into a medical safety role in MedTech
Regulating generative AI needs a new approach. Here is one idea.
Quick Tip: Make sure everyone has the same understanding of risk terminology
LTR 57: It's time to focus on supply chain resiliency not just supplier management
Business acumen - new LTR feature to help you achieve the success you deserve
Quick Tip: A simple trick to establish a risk policy
LTR 56: How to communicate effectively with senior management
Webinar 10: Tips for medical device software risk analysis
Quick Tip: Integrate supplier risk with product risk in your FMEAs
LTR 55: FDA warning letter analysis, IVD risk management and career tips with Dr. Emanuel Tkach
Medical Device News Update - May 2024
Quick Tip: Like container ships, connected medical devices need a new approach to risk management
LTR 54: Start your risk analysis by first defining the intended use
Quick Tip: Post-market surveillance is an active process not passively monitoring complaints
LTR Weekly Digest #40 - 15th June, 2024
QMSR Tip #1: Focus less on compliance and more on building a quality culture
Quick Tip: Understand patient perspective to design better products
LTR 53: Three big trends to watch in MedTech
AMA #4: How to estimate the probability of software failure and analyze risk?
Quick Tip: Manage AI/ML risk at the system level, not just in software.
LTR Weekly Digest #39 - 1st June, 2024
LTR 52: The key to success as a risk practitioner in the medical device industry.
Webinar 9: How to set up post-market surveillance
Quick Tip: Create design inputs from system level user needs and safety requirements
LTR Weekly Digest #38 - 25th May, 2024
LTR 51: Fidelis lead recall, probability and statistics, and career tips with Eric Maas
AI in MedTech #2: Insights from 882 device approvals through March 2024
Quick Tip: Duration of hazard exposure affects severity of harm
LTR Weekly Digest #37 - 18th May, 2024
LTR 50: Humility is the key to startup success
Medical Device News Update - April 2024
Quick Tip: Link reliability targets to design requirements and risk analysis
LTR Weekly Digest #36 - 11th May, 2024
RM roundup #3: 10 noteworthy risk-related LinkedIn posts
Delay in treatment can be deadly; analyze it carefully
Quick Tip: Create a safe environment to foster collaboration
LTR Weekly Digest #35 - 4th May, 2024
LTR 49: A clinician's view on AI/ML enabled medical devices
Webinar 8: Case study discussion and Q&A
Quick Tip: Treat QMSR practically as ISO 13485 international standard
LTR Weekly Digest #34 - 27th April, 2024
LTR 48: Integrating purchasing controls across product lifecycle
5 frequently asked questions about QMSR
Quick Tip: Don't ignore quality of life benefit of your medical device
LTR Weekly Digest #33 - 20th April, 2024
LTR 47: Cloud computing in MedTech, evolving regulatory landscape and career tips with Randy Horton
Medical Device News Update - March 2024
Quick Tip: Collaborate with medical safety colleagues for harm severity assignment
LTR Weekly Digest #32 - 13th April, 2024
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